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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bifidobacterium breve Bif195
Placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Probiotics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre Hospital, Copenhagen University
  • Copenhagen University Hospital Hvidovre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bif195 capsules

Placebo capsules

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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.
Change from baseline in abdominal pain at 8 weeks
Measured by a VAS scale from 0-10. 0 = no pain, 10 = worst pain
Adverse events
Reported according to IHC-GCP

Full Information

First Posted
March 4, 2021
Last Updated
July 5, 2023
Sponsor
Hvidovre University Hospital
Collaborators
Chr Hansen
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1. Study Identification

Unique Protocol Identification Number
NCT04808271
Brief Title
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome
Official Title
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Chr Hansen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bif195 capsules
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium breve Bif195
Intervention Description
1 capsule daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 capsule daily for 8 weeks
Primary Outcome Measure Information:
Title
Change in IBS symptoms from baseline measured by IBS-severity scoring system (IBS-SSS) at 8 weeks
Description
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 Outcome Measure Information:
Title
Change in quality of life from baseline measured by Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores at 8 weeks
Description
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
Title
Changes from baseline in bowel habits at 8 weeks
Description
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
Title
Change from baseline in abdominal pain at 8 weeks
Description
Measured by a VAS scale from 0-10. 0 = no pain, 10 = worst pain
Time Frame
8 weeks
Title
Adverse events
Description
Reported according to IHC-GCP
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hvidovre Hospital, Copenhagen University
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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