NCT04808271

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

March 4, 2021

Last Update Submit

July 5, 2023

Conditions

Irritable Bowel Syndrome

Keywords

Probiotics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    8 weeks

  • Changes from baseline in bowel habits at 8 weeks

    8 weeks

  • Change from baseline in abdominal pain at 8 weeks

    8 weeks

  • Adverse events

    16 weeks

Study Arms (2)

Bif195 capsules

ACTIVE COMPARATOR

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

Placebo capsules

PLACEBO COMPARATOR

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

Interventions

Bifidobacterium breve Bif195DIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

Bif195 capsules
PlaceboDIETARY_SUPPLEMENT

1 capsule daily for 8 weeks

Placebo capsules

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Abnormal screening biochemistry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hvidovre Hospital, Copenhagen University

Hvidovre, Copenhagen, 2650, Denmark

Location

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 22, 2021

Study Start

April 16, 2021

Primary Completion

May 9, 2023

Study Completion

May 9, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)