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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2023-05-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Bifidobacterium breve Bif195

Intervention Type DIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

Interventions

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Bifidobacterium breve Bif195

1 capsule daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 capsule daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No