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Completed

NCT Number: NCT04808271

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

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).

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital, Copenhagen University, Hvidovre, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium breve Bif195

Dietary Supplement

1 capsule daily for 8 weeks

Placebo

Dietary Supplement

1 capsule daily for 8 weeks

Primary outcomes

  1. Change in IBS symptoms from baseline measured by IBS-severity scoring system (IBS-SSS) at 8 weeks

    Time frame: 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).

Secondary outcomes

  1. Change in quality of life from baseline measured by Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores at 8 weeks

    Time frame: 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)

  2. Changes from baseline in bowel habits at 8 weeks

    Time frame: 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.

  3. Change from baseline in abdominal pain at 8 weeks

    Time frame: 8 weeks

    Measured by a VAS scale from 0-10. 0 = no pain, 10 = worst pain

  4. Adverse events

    Time frame: 16 weeks

    Reported according to IHC-GCP

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Chr Hansen

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2021
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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