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

NCT03266484 | Completed

• 1 other identifier: 2017P001489
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Microbiome; Fatigue; Probiotics

Outcome Measures

Primary Outcomes (4)

• Change in gut microbiome

  Change in fecal microbiome pattern assessed using 16sRNA sequencing.

  Week 12

• Change in serum inflammatory cytokines levels

  Change in inflammatory cytokines will be performed using the Biosciences Cytometric Bead Array kits.

  Week 12

• Change in metabolomic profiles

  Change in metabolic profiling will be performed on serum samples using established targeted quantitative and semi-quantitative gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) methods

  Week 12

• Change in fatigue symptoms

  Reduction of fatigue symptoms which will be assessed using FACIT-F questionnaire. FACIT-F score of \>43 at week 4 or week 12

  Week 4 and Week 12

Study Arms (2)

Probiotic Mixture

ACTIVE COMPARATOR

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.

Dietary Supplement: Probiotic Mixture

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Probiotic Mixture 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.

Probiotic Mixture

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Winclove Bio Industries BV: collaborator

Study Sites (1)

Crohn's and Colitis Center, MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Fatigue

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashwin N Ananthakrishnan, MBBS, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Will be a double blinded randomized controlled trial. Masking will be done by the provider of the probiotics/placebo
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: November 13, 2017
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)