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Probiotics for Inflammatory Bowel Disease

N/A

Waitlist Available

Led By Ashwin N Ananthakrishnan, MBBS, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Quiescent disease defined as Harvey Bradshaw index < 4 at baseline (week 0) or SCCAI < 2

Confirmed CD or UC or IBD-unspecified diagnosed according to standard criteria

Must not have

Untreated severe depression or anxiety

Patients with clinical or endoscopically active inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 and week 12

Summary

This trial is a single-site, randomized, double-blind, placebo-controlled trial of a probiotic supplement. The study will last 12 weeks and will compare the effects of the probiotic on the gut microbiome, metabolomic profile, and fatigue symptoms in patients with quiescent IBD.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones from probiotics may include digestive discomfort such as gas or bloating. The trial includes follow-up visits to monitor any adverse events from taking the probiotic mixture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 18 and 75 years old.

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I constantly feel very tired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have active inflammatory bowel disease.

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I am not pregnant or breastfeeding.

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

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I have a J-pouch or a stoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in fatigue symptoms

Change in gut microbiome

Change in metabolomic profiles

+1 more

Trial Design

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.

0 / 9Eligibility criteria met