The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Detailed Description
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IBS is the most frequently diagnosed gastrointestinal disease and also the most common cause of referrals to gastroenterology departments in Denmark. The possibilities for treatment for IBS are limited. Treatment strategies that involve the microbiota provide symptom relief in some IBS patients. Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls. Probiotic interventions has shown promising results, but it currently remains unknown which probiotics are effective and which are not. A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid, and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in IBS patients.

Official Title
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The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium breve Bif195
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with IBS-D defined as more than one-fourth (25%) of bowel movements with Bristol Stool Scale Types 6-7 and less than one-fourth (25%) with Types 1-2 Fulfill Rome IV diagnostic criteria for IBS Moderate to severe disease activity (IBS-SSS ≥175) Able to read and speak Danish Normal colonoscopy (performed within 1 year) if the patient had blood in stool Exclusion Criteria: Other chronic gastro intestinal diseases including lactose intolerance and coeliac disease Fecal calprotectin ≥50 mg/kg Fecal sample positive for enteropathogenic microorganisms Surgical interventions in the GI region (except for appendectomy, hernia repair, cholecystectomy and gynecological and urological procedures) Psychiatric disorder Abuse of alcohol or drugs Medications except birth control pills, hormone supplements, allergies/asthma agents, blood pressure and cholesterol-lowering agents, proton pump inhibitors and non-prescription medicines; abnormal colonoscopy findings Pregnancy, planned pregnancy or breastfeeding females Ingestion of probiotics or antibiotics <4 weeks before the inclusion Abnormal screening biochemistry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bif195 capsules<br>The capsule will contain approximately 15*10^9 CFU of Bif195 per day. Excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule. | Dietary Supplement: Bifidobacterium breve Bif195<br>* 1 capsule daily for 8 weeks<br>|
| Placebo Comparator: Placebo capsules<br>The capsule contain only excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule. | Dietary Supplement: Placebo<br>* 1 capsule daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IBS symptoms from baseline measured by IBS-severity scoring system (IBS-SSS) at 8 weeks | IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life. Each measure is rated from 0 to 100, with total scores ranging from 0 (best) to 500 (worst). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life from baseline measured by Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores at 8 weeks | The IBS-QoL questionnaire consists of 34 items, each with a 5-point response scale. The 34 items are based on the following eight variables: health worries, food avoidance, body image, dysphoria, interference with activity, social reactions, sexual activity and relationships. The IBS-QoL score will be transformed into a 0-100 scale using the formula: total score = (sum of the items-34/170) ×100. Low score (best) | 8 weeks | 
| Changes from baseline in bowel habits at 8 weeks | measured by frequency/day and Bristol Stool Form Scale. The Bristol Stool Form Scale is divided into seven categories were a low value indicate constipation and a high value indicate diarrhoea. | 8 weeks | 
| Change from baseline in abdominal pain at 8 weeks | Measured by a VAS scale from 0-10. 0 = no pain, 10 = worst pain | 8 weeks | 
| Adverse events | Reported according to IHC-GCP | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics