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

Hvidovre University Hospital61 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

Bifidobacterium breve Bif195DIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

PlaceboDIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Hvidovre Hospital, Copenhagen University

Hvidovre, Copenhagen, Denmark

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark

Outcomes

Primary Outcomes

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).

Time frame: 8 weeks

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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

Time frame: 8 weeks

Adverse events

Reported according to IHC-GCP

Time frame: 16 weeks

Data from ClinicalTrials.gov

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