Irritable Bowel Syndrome - U.S. Pharmacist key aspect of these guidelines is the impor-tance of strain-specificity in clinical ev aluations of probiotics. Hundreds of probiotic products

DISEASE STATE INFORMATION GUIDE

M

AY 2009

®

Irritable Bowel Syndrome:Overview of Diagnosis and Management of IBS

Focus on Probiotics

This Disease State Information Guide is supported by a grant from P&G

©GETTYIMAGES/3D4MEDICAL

IRRITABLE BOWEL SYNDROME (IBS)Irritable bowel syndrome (IBS) is a chronic con-dition associated with uncomfortable or painfulbowel symptoms that are not associated with organicdisease or structural abnormalities. The symp-toms of IBS are quite variable among individualsand occur in episodic “flares” of adverse changesin bowel habits, including diarrhea, constipation,bloating, excess gas, and urgency. The patterns ofIBS symptoms are referred to as diarrhea-pre-dominant, constipation-dominant, or alternatingbetween diarrhea and constipation1.

The etiology of IBS is not known. Patients maydevelop IBS after enteric infections or followingsignificant life changes, such as traumatic eventsor serious illness, but in some patients no pre-cipitating events can be identified. The “brain-gut” connection that regulates bowel motility, sen-s i t iv i ty, secret ion, and absorpt ion through

serotonin-based signaling mechanisms is an impor-tant factor, but the exact neurological mechanismsthat result in IBS symptoms are not known. Onthe other hand, overgrowth of endogenous gutmicroflora or expansion of bacteria into the smallbowel have been documented in many patientswith IBS. These imbalances may be related to dis-turbances of the brain-gut connection; however,the nature of the relationship between these find-ings is not well understood2,3. Due to these uncer-tainties, therapies for IBS are generally targetedat relief of symptoms rather than interference withspecific disease processes2,3.

DIAGNOSIS OF IBSThere are no definitive diagnostic tests or patholo-gies that can be used to diagnose IBS. Sets of symp-tom criteria have been developed to define the com-plex of symptoms that allow diagnosis of IBS in

Irritable Bowel Syndrome:Overview of Diagnosis and Management of IBS

Focus on Probiotics

U.S. PHARMACIST MAY 20092

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the absence of warning signs that may indicateorganic disease. Rome III criteria, the mostrecent set of IBS criteria, were published in 2006and are widely used in clinical trials1.

According to Rome III criteria and in the absenceof warning signs, IBS is diagnosed if the patienthas experienced recurrent abdominal pain or dis-comfort on at least 3 days per month in the pre-vious 3 months and at least 2 of the following signs:1) pain or discomfort is improved with defecation;2) onset of pain or discomfort is associated with achange in frequency of stool; 3) onset of pain ordiscomfort is associated with a change in theform of stool. The onset of these symptoms musthave at least 6 months prior to diagnosis and thecriteria must be fulfilledfor at least the previous 3months (TABLE 1)4. Warn-ing signs that may indicateorganic disease or struc-tural abnormalities includerectal bleeding, anemia,weight loss, fever, familyhistory of colon cancer,onset of symptoms after 50years of age, and a majorchange in symptoms2.

PREVALENCE ANDIMPACT OF IBSSurvey studies that usedthe Rome criteria for IBSindicate a prevalence ofapproximately 7% in theNorth American population1. These surveys alsoshowed that women are 1.5 times more likely todevelop IBS than men. However, IBS is includedin the definition of Gulf War syndrome in a pre-dominantly male population of military person-nel, showing that IBS should not be considered adisorder of women alone1. Persons under 50 yearsof age are more often diagnosed with IBS than olderindividuals and prevalence is higher in demographicgroups with low income compared with groupswith higher income1,5.

IBS prevalence in the United States may be sig-nificantly higher than these figures indicate. A2005 community survey documented a prevalencerate of 14%, with only 3% reporting an actualmedical diagnosis of IBS6. As many as 70% ofpatients who have IBS may not seek medicalcare for their symptoms7.

Patients with IBS report significant impact oftheir condition on quality of life. A large com-parative study using the SF-36 Health Surveyshowed that patients with IBS had significantlyworse health-related quality of life (HRQOL) thanthe general population. These patients also scoredsignificantly lower than patients with diabetes andend-stage renal disease8.

MANAGEMENT OF IBS SYMPTOMSMany patients perceive thatspecific foods cause orincrease IBS symptoms andexclude them from theirdiet. While this strategy isused by 60-70% of patients,it may lead to poor nutri-tion in some patients. Thesefood intolerances are notrelated to food allergies ormalabsorption9.

Pharmacological thera-pies are usually aimed atnormalizing bowel habitsor decreasing abdominalpain. Recommendations for

use of many pharmacological agents for IBS is basedon general consensus of experts, rather than ran-domized clinical trials in patients with IBS. In addi-tion, evidence for efficacy of these agents may belimited to individual symptoms, such as constipa-tion or diarrhea, rather than for global improve-ment in IBS symptoms2.

Prescription agents. Lubiprostone, a calcium-channel activator, increases bowel motility byincreasing intestinal fluid secretion and is indi-cated for chronic idiopathic constipation. Adverse

IRRITABLE BOWEL SYNDROME


Table 1. Rome III Criteria for Diagnosis of Irritable Bowel Syndrome4

Recurrent abdominal pain or discomfort

Occurred at least 3 days per month in the previous 3 months

Pain or discomfort is associated with 2 or more of the following:

Relieved with defecation

Onset is associated with change in frequency of stool

Onset is associated with change in form (appearance) of stool

Criteria must be fulfilled for the previous 3 months with onset at least 6 monthsbefore diagnosis

Absence of warning signs of organic disease or structural abnormalities

events associated with lubiprostone include nau-sea, diarrhea, headache, and abdominal pain ordiscomfort10.

Tegaserod is an agonist of 5-HT4 receptors forserotonin, the primary neurotransmitter involvedin brain-gut neurological connections. Activationof 5-HT4 receptors stimulates peristaltic activityand internal fluid secretion and also decreases vis-ceral sensitivity11. Tegaserod is indicated for con-stipation-predominant IBS and chronic idiopathicconstipation in women. However, tegaserod is avail-able only on a very limited basis for women withthese conditions and without cardiovascular riskfactors, because of rare but severe cardiovascularischemic adverse events. Initial diarrhea and abdom-inal pain may also occur11.

Alosetron is an antagonist of the 5-HT3 recep-tor for serotonin. Inhibition of this receptor resultsin less hypersensitivity and lowered motor responsesin the bowel12. Alosetron is indicated only forwomen with severe diarrhea-predominant IBS thathas not responded to other treatments, due to theinfrequent but serious potential for ischemic col-itis. Constipation may also be an adverse event12.

Antispasmodic agents, such as hyoscyamineor mebeverine, are sometimes prescribed for treat-ment of IBS-related pain. These agents may beeffective for some patients, but large-scale clini-cal trials in IBS have not been performed2. Onthe other hand, tricyclic antidepressants, such as

amitriptyline and desipramine, are often prescribedat low doses for IBS symptoms. These agents pro-long exposure to neurotransmitters, such asserotonin and norepinephrine, by blocking uptakeby neurons13,14. At low doses, these agents maybenefit patients with IBS by decreasing hyperal-gesia, improving sleep, and normalizing boweltransit times15. Improvement of coexisting depres-sion or anxiety may also occur when used at thehigher doses recommended for these disorders2.In addition, the selective serotonin-reuptakeinhibitors (SSRIs) paroxetine, citalopram, and flu-oxetine have been studied in patients with IBSin several clinical trials. These agents may have adirect ef fect on IBS symptoms of pain andbloating as well as psychological effects on depres-sion and anxiety16.

Finally, the nonabsorbable antibiotic rifaximin,which has been shown to inhibit bacterial over-growth in the bowel17, improved global IBS symp-toms and the individual symptom of bloating,in a small randomized clinical trial. However, itis not approved for this indication. The benefitof improved symptoms lasted for up to 10 weeksafter discontinuation of treatment. Individualscores for pain, diarrhea, and constipation did notchange18.

Non-prescription agents. Constipation may betreated with traditional laxatives, such as polyethy-lene glycol 3350 or lactulose. Diarrhea, bloating,



GENUS

This is a group of closely related species

Bifidobacterium infantis 35624

Figure 1. Bacterial Nomenclature in Probiotic Products

Information for probiotic products should identify the genus, species, and strain of the bacteria.23

SPECIES

This is a group of individual bacteria that

share similarities

STRAIN DESIGNATION

The specific bacteria in the

product

and cramping are potential adverse events ofthese agents2. Traditional antidiarrheal agents, suchas loperamide, are generally effective for patientswith diarrhea-predominant IBS. Regular use of low

doses of loperamide, in particular, have been rec-ommended to relieve uncontrollable diarrhea anddecrease patients' anxiety about urgency. Consti-pation is a potential adverse event2.

FOCUS ON PROBIOTICS FOR MANAGEMENT OF IBS SYMPTOMSProbiotics are live microorgan-isms that confer health benefitswhen administered in adequateamounts. Because of the associ-ation between IBS and imbalancesor overgrowth of gut microflora,probiotics in oral supplementsand such foods as yogurt havebeen widely publicized for help-ing patients achieve relief fromsymptoms. To promote adequateclinical investigation of theseeffects, guidelines for the evalu-ation of the health benefits of oralprobiotics have been set forthby the World Health Organiza-tion (WHO), the InternationalScientific Association for Probi-otics and Prebiotics (ISAPP), andthe World Gastroenterology Organ-isation (WGO) (FIGURE 1) 19,20,21.



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L. SalvariusB. Infantis Placebo

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Figure 2. Effect of Bifidobacterium infantis 35624 on Composite Scores of IBS Symptoms 23

Figure 3. Comparison of effects of placebo and Bifidobac-terium infantis 35624 on Subjects’ Global Assessment

(SGA) of IBS symptoms. Positive response rates recordedat wk 4 at the end of therapy - “yes” or “no” response: “Please consider how you felt in the past week in regard to your IBS, in particular your general well-being, and symptoms of abdominal discomfort or pain, bloating

or distension and altered bowel habit. Compared to the way you felt before beginningthe medication, have you had adequate relief of your IBS symptoms?”

Source: O’Mahony et al. Gastroenterology 2005;128:541-551.

Whorwell et al. Am J Gastroenterol 2006;101:1581-1590.

A key aspect of these guidelines is the impor-tance of strain-specificity in clinical evaluations ofprobiotics. Hundreds of probiotic products havebeen promoted for relief of gastrointestinal symp-toms and may contain one or more differentmicroorganisms and strains. However, the guide-lines agree that consistent identification of microor-ganisms down to the strain level is needed toverify that clinical studies were conducted withexactly the same strain as those in commercialproducts. Specification of well-characterized strainsalso assures that the identity, quality, and safetyof the administered microorganism used forclinical trials and commercial products can be ver-ified consistently19.

A second important factor in the correspondencebetween clinical studies and commercial productsis the level of colony-forming units (CFUs) of themicroorganism in each case. The level of viableorganisms that was tested and found effective inclinical studies should be the same as that in thecommercial product for the specified shelf life2.

It is clear from these guidelines that all probi-otic products are not alike in their characteristics,quality, and effects on gastrointestinal symptoms.The probiotics found in commercial productsand foods may be different organisms at differentlevels. Because of these differences, the effects ofprobiotics are often not adequately confirmed inclinical studies to support claims of health bene-fits20. Thus, it is particularly important to recom-

mend probiotics from a reputable manufacturerthat has thoroughly tested and verified the safetyand potency of specific products in clinical trials.Patient information that accompanies probioticproducts should provide clear information that willensure proper storage and use of probiotics sothat organisms remain at levels of viability andpotency that were effective in clinical trials.

Several strains of probiotic organisms have beentested in randomized, controlled clinical trials inpatients with IBS with inconsistent results in thesestudies. (TABLE 2)22. This is not a comprehensivelist of products but includes several that may beavailable in United States pharmacies, health-food stores, or online. Bifidobacterium infantis35624 is the only probiotic product to have metprimary efficacy endpoints in randomized, con-trolled clinical trials.

The probiotic supplement Bifidobacteriuminfantis 35624 has recently been tested in 2 ran-domized, placebo-controlled clinical trials in maleand female patients with IBS. In one study of77 patients, symptoms of pain, bloating, andbowel movement difficulty were improved inpatients who received Bifidobacterium infantis35624 compared with those who received a lac-tobacillus supplement and compared with placebotreatment (FIGURE 2)23. In the second study of362 female patients, global IBS symptoms, as wellas the individual symptoms of abdominal pain,bowel dysfunction, incomplete evacuation, strain-



Table 2. Probiotic strains tested in randomized, controlled clinical trials in patients with IBS21,22,25

Met 1o endpointStrain Trade name Manufacturer in clinical trials

Bifidobacterium infantis 35624 Align Procter & Gamble Yes

Bifodobacterium animalis DN 173 010 Activia Danone/Dannon No

Lactobacillus rhamnosus ATCC 53013 (LGG) Vifit Vatio No

Lactobacillus reuteri ATCC 55730 Reuteri BioGaia Biologics No

Lactobacillus plantarum 299V GoodBelly NextFoods No

Mixture of 1 strain Streptoccoccus VSL#3 Sigma-Tau Nothermophilus, 4 Lactobacillus spp., (medical food)3 Bifidobacterium spp. strains



REFERENCES1. American College of Gastroenterology Task Force on IBS. Anevidence-based systematic review on the management of irritablebowel syndrome. Am J Gastroenterol 2009;104(Suppl 1):S1-S35.2. Mayer EA. Irritable bowel syndrome. New Engl J Med2008;358:1692-1699.3. Lin HC. Small intestinal bacterial overgrowth: a frameworkfor understanding irritable bowel syndrome. JAMA2004;292:852-858.4. Longstreth GF, Thompson WG, Chey WD, Houghton LA,Mearin F, Spiller RC. Functional bowel disorders. Gastroenterol-ogy 2006;130:1480-1491.5. Andrews EB, Eaton SC, Hollis KA, et al. Prevalence anddemographics of irritable bowel syndrome: results from a largeweb-based survey. Aliment Pharmacol Ther 2005;22:915-942.6. Hungin APS, Chang L, Locke GR, Dennis EH, Barghouts V.Irritable bowel syndrome in the United States: prevalence, symptompatterns and impact. Aliment Pharmacol Ther 2005;21:1365-1375.7. Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGAtechnical review on irritable bowel syndrome. Gastroenterology2002;123:2108-2131.8. Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA.The impact of irritable bowel syndrome on health-related qualityof life. Gastroenterology 2000;119:654-660.9. Monsbakken KW, Vandvik PO, Farup PG. Perceived foodintolerance in subjects with irritable bowel syndrome - etiology,prevalence and consequences. Eur J Clin Nutr 2006;60:667-672.10. Amitiza™ (lubiprostone) [prescribing information]. Lin-colnshire, IL: Takeda Pharmaceuticals America, Inc.; 2006.11. Zelnorm™ (tegaserod maleate) [prescribing information].East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2002.12. Lotronex (alosetron hydrochloride) [prescribing informa-tion]. San Diego, CA: Prometheus Laboratories, Inc.; 2008.13. Elavil® (amitryptyline HCl) [professional informationbrochure]. Wilmington, DE: Zeneca Pharmaceuticals; 2000.14. Norpramin® (desipramine hydrochloride) [prescribing infor-mation]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; 2006.15. Clouse RE, Lustman PJ. Use of psychopharmacologicalagents for functional gastrointestinal disorders. Gut2005;54:1332-1341.16. Mayer EA, Tillisch K, Bradesi S. Review article: modulation

of the brain-gut axis as a therapeutic approach in gastrointestinaldisease. Aliment Pharmacol Ther 2006;24:919-933.17. Di Stefano M, Malservisi S, Veneto G, Ferrieri A, CorazzaGR. Rifaximin versus chlortetracycline in the short-term treat-ment of small intestinal bacterial overgrowth. Aliment PharmacolTher 2000;14:551-556.18. Pimentel M, Park S, Mirocha J, Kane SV, Kong Y. Theeffect of a nonabsorbed oral antibiotic (rifaximin) on the symp-toms of the irritable bowel syndrome: a randomized trial. AnnIntern Med 2006;145:557-563.19. Food and Agriculture Organization of the UnitedNations/World Health Organization. Guidelines for the Evalua-tion of Probiotics in Food. Available athttp://www.who.int/foodsafety/fs_management/en/probiotic_guidelines.pdf. Accessed March 24, 2009.20. International Scientific Association for Probiotics and Prebi-otics. The Ps and Qs. of Probiotics: a Consumer Guide for Mak-ing Smart Choices. Available at: http://isapp.net/docs/Con-sumer_Guidelines-probiotic.pdf . Accessed March 24, 200921. World Gastroenterology Organisation Practice Guideline.Probiotics and prebiotics. Available at http://www.worldgas-troenterology.org/assets/downloads/en/pdf/guidelines/19_probi-otics_prebiotics.pdf. Accessed March 24, 2009.22. Hoyveda N, Heneghan C, Mahtani KR, et al. A systematicreview and meta-analysis: probiotics in the treatment of irritablebowel syndrome. BMC Gastroenterol 2009;15. Available athttp://www.biomedcentral.com/1471-230X/9/15. Accessed April14, 2009.23. O’Mahoney L, McCarthy J, Kelly P, et al. Lactobacillus andBifidobacterium in irritable bowel syndrome: symptom responsesand relationship to cytokine profiles. Gastroenterology2005;128:541-551.24. Whorwell PJ, Altringer L, Morel J, et al. Efficacy of anencapsulated probiotic Bifidobacterium infantis 35624 in womenwith irritable bowel syndrome. Am J Gastroenterol2006;101:1581-1590.25. Brenner DM, Moeller MJ, Chey WD, Schoenfeld PS. Theutility of probiotics in the treatment of irritable bowel syndrome:a systemic review. Am J Gastroenterol advance online publica-tion. Available at www.amjgastro.com. Accessed March 10,2009.

ing, and gas were significantly improved com-pared with placebo (FIGURE 3)24. It should benoted that Bifidobacterium infantis 35624 waseffective in all subtypes of IBS and in male andfemale patients.

CONCLUSIONIBS is a chronic condition that causes significantdecreases in quality of l i fe with episodes ofpainful or uncomfortable bowel symptoms thatmay be severe. Since the causes of IBS are notwell understood, treatments are targeted at indi-

vidual symptomology. Interference with serotonin-based signaling mechanisms that control the brain-gut connection and regulation of imbalances in gutmicroflora are the two main pharmacologicstrategies for treatment of IBS symptoms. Probi-otic therapy may provide relief through the latterstrategy; however, use of probiotic products thathave been identified to the species level andtested in randomized clinical trials is recommendedby international guidelines. This discriminationallows confidence in health claims supported byclinical trials of probiotic products.u

CAUSES OF IBSIBS is not the result of organic disease and nophysical or structural abnormalities are associ-ated with IBS. Patients may develop IBS symp-toms after a gastrointestinal infection, other majorillness, traumatic events, or stressful life situation.The neurological connections between the brainand the gut are known to be an important factorin regulation of bowel motility, absorption, andsensitivity. In addition, imbalances in the normalgut bacteria have been found in many patients andmay be responsible for IBS symptoms.

DIAGNOSIS OF IBS There is no test or specific pathology to identifyIBS. The patient with IBS should meet Rome cri-teria for the past 3 months, have had symptomsfor at least 6 months, and not have warning signsthat may indicate organic disease. Warning signs

that may indicate diseases other than IBS includerectal bleeding, anemia, weight loss, fever, familyhistory of colon cancer, onset of symptoms after50 years of age, and a major change in symptoms.

MANAGEMENT OF IBS SYMPTOMSTreatment options for IBS are targeted at normalizingbowel habits and reducing abdominal discomfort. Mostpatients find that certain foods may trigger episodes ofIBS and learn to avoid them to reduce symptoms.Traditional over-the-counter medications for diarrheaor constipation are sometimes recommended for indi-vidual symptoms, but may have no effect on abdomi-nal pain or bloating. Several prescription medicationsthat affect the “brain-gut” connection have been devel-oped for IBS, depending on the type of symptoms thepatient is experiencing. These include alosetron (fordiarrhea-predominant IBS) and tegaserod or lubipro-stone (for constipation-predominant IBS).

PATIENT INFORMATION AID


Irritable bowel syndrome (IBS) is a chronic condition characterized by abdominal pain or discomfort with recurrent

episodes of such symptoms as diarrhea, bloating, constipation, gas and bloating, and urgency. The patterns of IBS symptoms and

their severity vary widely among patients. Symptoms are usually classified as diarrhea-predominant, constipation-predominant, or alternating.

Should I tell my healthcare provider about IBS symptoms?The majority of individuals with IBS do not consult a healthcare provider about their symptoms,even when the symptoms have a major effect on their lives. However, many IBS symptoms can bereduced or even eliminated by strategies and medications that are now available. When you first visityour healthcare provider about IBS symptoms, be ready to tell him or her the following information:

Kinds of symptoms and how long they have been occurring.

How often they occur

How IBS symptoms affect your family life, work situation, and social life.

Whether you can identify foods or situations that make IBS symptoms worse

Whether you do anything to help your IBS symptoms (food avoidance, supplements, etc.)

Prescription and over-the-counter medications you take now

International Foundation for Functional Gastrointestinal DisordersPO Box 170864Milwaukee, WI 53217-8076Phone: (414) 964-1799Toll-free: (888) 964-2001Fax: (414) 964-7176E-mail: [email protected]://www.iffgd.org/IBS web sites: http://www.aboutibs.org/ andhttp://www.iamibs.org/

The American College of GastroenterologyP.O. Box 342260Bethesda, MD 20827-2260Phone (301) 263-9000http://www.acg.gi.org/

World Digestive Health Day 2009—Irritable Bowel SyndromeThe World Gastroenterology Organisation focuses theattention of the world gastroenterology community (medicalprofessionals, other healthcare workers, and the generalpublic) on IBS on May 29, 2009.http://www.worldgastroenterology.org/wdhd-2009.html

American Gastroenterological Association4930 Del Ray AvenueBethesda, MD 20814Phone: (301) 654-2055 Fax: (301) 654-5920E-mail: [email protected]://www.gastro.org/wmspage.cfm?parm1=2

International Scientific Association for Probiotics and Prebiotics502 Mace Blvd. Suite 12Davis, California95618 USAPhone (530) 753-0681http://isapp.net/

National Center for Complementary and Alternative MedicineNational Institutes of Health9000 Rockville PikeBethesda, Maryland 20892 USAE-mail: [email protected] http://nccam.nih.gov/

PATIENT INFORMATION AID


RESOURCESIRRITABLE BOWEL SYNDROME (IBS) AND PROBIOTICS

Low doses of antide-pressants are sometimeseffective for abdomi-nal pain in patientswith IBS, because ofthe neurological con-nections between thebra in and the gut .These agents are gen-erally given at lowerdoses than would beeffective for mood dis-orders. Symptoms ofbloating and gas havebeen shown to beaffected by agents thatchange the balance ofbacteria in the gut, such as antibiotics. Probi-otic foods and supplements have received con-siderable promotion for improvement of intesti-nal health. The quality of these claims for probiotic

products is difficult toascertain unless themicroorganisms havebeen standardized, iden-tified to the strain level,and tes ted in ran-domized clinical trials.Recommendations forprobiotics for patientswith IBS should be sup-ported by data fromstudies specifically inthis population. Theprobiotic supplementBifidobacterium infan-t i s 35624 has beenfound effective in ran-

domized, placebo-controlled clinical trials forglobal IBS symptoms, as well as the individualsymptom of bloating in men and women with allsubtypes of IBS.u

Illustration of polysaccharide coated Bifidobacterium infantis 35624attached to epithelial cells to create a natural defense.

Q: My physician told me I have IBS. How isIBS diagnosed?

A: IBS is diagnosed by a set of symptoms andhow long they have occurred, not by aspecific test. A healthcare provider takes acareful history of all your abdominalsymptoms and how long they have beenoccurring. The healthcare provider may alsoinquire about other symptoms, such asanemia or weight loss, to be sure thatanother disease is not present. If thesesymptoms are present, or if you have afamily history of other digestive diseases orcancer, more tests may be indicated.

Q: What can I do to improve my IBSsymptoms?

A: Many patients find that certain foods triggertheir symptoms or make them worse. If youkeep track of which foods do this, avoidancemay help reduce the severity or thefrequency of IBS episodes. Your physicianshould be aware of your diet changes inorder to tell if you need to try other kindsof therapy.Probiotics may be another option to try toreduce your IBS symptoms. These work byadding beneficial bacteria to your system.Many probiotic products make claims forimproving intestinal health, but only a fewhave actually been tested in patients withIBS. It is important to choose one that hasbeen standardized and thoroughly tested by

a reputable manufacturer. For patients withIBS, claims should be backed up byrandomized, controlled clinical trials thatwere conducted in individuals with IBS.

Q: What kinds of therapy are available forIBS symptoms?

A: Depending on the kind of IBS symptomsyou have, your healthcare provider maydetermine that several different therapiesmay help. Some medications focus on theconnections between the gut and the brainthat control how material moves throughyour digestive system and how sensitiveyour system is. Like all medications, theremay be side effects (some serious) andcontraindications to use of these therapiesin your particular case. Other kinds ofmedications influence the kinds of bacteriathat are naturally present in the smallintestine. Gut bacteria have been shown tobe unbalanced or in the wrong part of thegut in some patients with IBS, so thesemedications are used to try to restore theproper numbers and types of bacteria in thesmall intestine. Probiotics are not drugs, butsupplementation of live bacteria that mayhelp the balance in the gut.

Q: I have seen advertising for probioticfoods and supplements that are supposedto improve digestive health. What areprobiotics?

COUNSELING CORNER


The following series of questions and answers serves as a patient education aid to assist health care professionals in counseling

patients with irritable bowel syndrome (IBS).

A: Probiotic foods (such as yogurt) andsupplements contain live bacteria that maybenefit digestion by changing the patternof bacteria in the gut. Many probioticshave been claimed to help with such IBSsymptoms as bloating, diarrhea, andconstipation. However, it may be difficultto tell how many beneficial bacteria andwhat types are present in foods andsupplements. This makes it particularlyimportant to buy supplements made by areputable manufacturer who hasthoroughly tested the exact type of bacteriathat is used in the supplement in clinicaltrials.

Q: If I take a probiotic supplement, whatshould I look for?

A: You should ask your healthcare provider tobe sure that there is no reason why youshould not take a probiotic supplement.Most people who do not have other seriousdiseases can take a probiotic safely. Theinformation for a probiotic supplementshould clearly state the exact type andstrain of bacteria in the supplement andhow many bacteria are in each serving. Itshould tell you how much to take and howoften to take it. It should also tell you howto store the probiotic so that the bacteriastay alive until the end of the “best by”period. The information should also tellyou what to expect when you begin takingthe probiotic and what to do if you misstaking it. You may want to keep track ofhow your symptoms change during the first3 to 4 weeks of using the probiotic. This ishelpful information for your healthcareprovider as well.

Q: How should I decide which probiotic to take?

A: The probiotic should be standardized andidentified down to the strain level of themicroorganism by a reputable manufacturer.Testing in clinical trials should have beendone in patients with IBS, so that thespecific symptoms you have were caused bythe same problems. Convenient methods forstoring the probiotic, so that themicroorganisms stay at peak effectivenessthroughout the "best by" period, may affect your choice as well. Finally, the ease oftaking the probiotic in a capsule or in extrafood may influence your choice.

Q. Can I take other probiotic foods orsupplements at the same time?

A. Yes, in general. However, you may not beable to tell which supplement is working asyou wished or which causes moresymptoms. In the same way as you mighttest foods to see if they affect your IBSsymptoms, probiotics can be added one at atime so that you understand their effects.

Q. Can I take other medications at the sametime as probiotic foods or supplements?

A. Yes, in general there are no interactionsbetween probiotics and other medications.However, if you have serious digestivedisease or other serious disease, check withyour healthcare provider before startingprobiotics.

Q. How long should it take for the effects ofprobiotics to start?

A. You may notice some changes in yourdigestive system in the first few days, but agood trial of a probiotic is 3 to 4 weeks.Some gas and bloating may occur at first.These effects should pass off and result inimproved symptoms by the end of a 4-weektrial period.u

COUNSELING CORNER


This Disease State Information Guide is supported by a grant from P&G

Documents

Irritable Bowel Syndrome - U.S. Pharmacist key aspect of these guidelines is the impor-tance of strain-specificity in clinical ev aluations of probiotics. Hundreds of probiotic products