Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease

NCT ID: NCT03266484

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2024-07-01

Brief Summary

The study is proposed as a single-site randomized double-blind placebo-controlled trial requiring 4 study visits, where two of the visits are combined with their appointment for routine clinical care. The study population will consist of patients with quiescent CD and UC and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible patients will be contacted at the time of their routinely scheduled office visit and consented for the study. Self-report and review of medical records will be used to obtain detailed information regarding their disease on an intake questionnaire completed by a research study coordinator.

The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic supplement compared to placebo. We propose to examine the effect of a specific probiotic supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue symptoms in patients with quiescent IBD.

Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline visit. The patient will receive either the probiotic supplement or placebo for 4 weeks.

The first follow up visit will be at week 4 to check for adverse events on study treatment, to check accountability of probiotics/placebo, and to complete the set of questionnaires. Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment.

At week 8, subjects will receive a phone call from a study research coordinator to check in with probiotics/placebo intake for treatment compliance and accountability records, and to complete the set of questionnaires ascertaining subjective symptoms.

Last study visit will be at week 12 which is often combined with a regular office appointment. Subject will provide serum blood and stool sample, as well as complete the set of questionnaires.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Probiotic Mixture

Participants who are meeting the inclusion criteria will be randomized to either the probiotic mixture or an identical placebo.

The probiotics sachets will be taken twice a day for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Probiotic Mixture

Intervention Type: DIETARY_SUPPLEMENT

The probiotic supplement contains 8 different strains of bacteria and participants will be dosed in two dosages per a total of 40 billion bacteria daily.

Placebo

Participants who are meeting the inclusion criteria will be randomized to either the probiotic mixture or an identical placebo

The identical placebo sachets will be taken twice a day for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

A placebo which is identical to the probiotic mixture. Participants will be dosed in two dosages daily.

Interventions

Probiotic Mixture

The probiotic supplement contains 8 different strains of bacteria and participants will be dosed in two dosages per a total of 40 billion bacteria daily.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A placebo which is identical to the probiotic mixture. Participants will be dosed in two dosages daily.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years
• Confirmed CD or UC or IBD-unspecified diagnosed according to standard criteria
• Quiescent disease defined as Harvey Bradshaw index < 4 at baseline (week 0) or SCCAI < 2
• Persistent ongoing fatigue symptoms
• Endoscopic or radiologic remission within 12 months of screening
• Washout of non-study probiotic supplements for at least 4 weeks prior to screening.

Exclusion Criteria

• Patients with clinical or endoscopically active inflammatory bowel disease
• Significant non-IBD comorbidity contributing to the fatigue (such as active cancer).
• Untreated severe depression or anxiety
• Known sleep disorders without adequate treatment,
• Presence of J-pouch or a stoma
• Ongoing use of other non-study probiotics
• Women who are pregnant or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winclove Bio Industries BV

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ashwin Ananthakrishnan

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashwin N Ananthakrishnan, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Crohn's and Colitis Center, MGH

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2017P001489

Identifier Type: -

Identifier Source: org_study_id