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NCT Number: NCT03266484

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Fatigue Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Crohn's and Colitis Center, MGH

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in gut microbiome

    Time frame: Week 12

    Change in fecal microbiome pattern assessed using 16sRNA sequencing.

  2. Change in serum inflammatory cytokines levels

    Time frame: Week 12

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

  3. Change in metabolomic profiles

    Time frame: Week 12

    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

  4. Change in fatigue symptoms

    Time frame: Week 4 and Week 12

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Winclove Bio Industries BV

Registry information

Official study title

Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2017
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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