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

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

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Bifidobacterium breve Bif195; Dietary supplement: Placebo

Detailed Description

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
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ida MB Grønbæk, MD; Phone Number: 004530366773; Email: ida.marie.bruun.groenbaek@regionh.dk
• Study Contact Backup: Name: Andreas M Petersen, MD, PhD; Phone Number: 004538626199; Email: andreas.munk.petersen@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Copenhagen University Hospital Hvidovre
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Hvidovre Hospital, Copenhagen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bif195 capsules; 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; 1 capsule daily for 8 weeks
Placebo Comparator: Placebo capsules; 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; 1 capsule daily for 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Chr Hansen

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: H-20060730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No