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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808271
• Other study ID #: H-20060730
• Status: Completed
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: May 9, 2023

Study information

• Verified date: July 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Bifidobacterium breve Bif195
1 capsule daily for 8 weeks
• Placebo
1 capsule daily for 8 weeks

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre	Hvidovre
Denmark	Hvidovre Hospital, Copenhagen University	Hvidovre	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Chr Hansen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse events	Reported according to IHC-GCP	16 weeks