Status:
COMPLETED
Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Winclove Bio Industries BV
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03266484
Start Date
November 13 2017
End Date
July 1 2024
Last Update
May 9 2025
Active Locations (1)
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1
Crohn's and Colitis Center, MGH
Boston, Massachusetts, United States, 02114