Probiotics for Inflammatory Bowel Disease

Palo Alto (17 mi)

Overseen byAshwin N Ananthakrishnan, MBBS, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Massachusetts General Hospital

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-75 with Crohn's Disease, Ulcerative Colitis, or unspecified IBD who are in remission but experiencing fatigue. They must not have used non-study probiotics for 4 weeks prior and should not be pregnant, lactating, or have severe untreated depression/anxiety.

Inclusion Criteria

My Crohn's disease or ulcerative colitis is currently under control.

I have been diagnosed with Crohn's disease, ulcerative colitis, or unspecified IBD.

I am between 18 and 75 years old.

I constantly feel very tired.

Exclusion Criteria

I have severe depression or anxiety that hasn't been treated.

I have active inflammatory bowel disease.

I am not pregnant or breastfeeding.

I have a sleep disorder that is not being treated properly.

I have a J-pouch or a stoma.

Treatment Details

The study tests a probiotic mixture against a placebo over 12 weeks to see if it affects the gut microbiome and reduces fatigue in patients with inactive inflammatory bowel disease. Participants will take the supplement or placebo and attend four visits including check-ins and questionnaires.

2Treatment groups

Active Control

Placebo Group

Group I: Probiotic MixtureActive Control1 Intervention

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 II: PlaceboPlacebo Group1 Intervention

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.