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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 March 2023
• Main ID: NCT03266484
• Date of registration: 25/08/2017
• Prospective Registration: Yes
• Primary sponsor: Massachusetts General Hospital
• Public title: Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease
• Scientific 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
• Date of first enrolment: November 13, 2017
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03266484
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Ashwin N Ananthakrishnan, MBBS, MPH
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Crohn Disease

Inflammatory Bowel Diseases

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Probiotic Mixture

Primary Outcome(s)

Change in metabolomic profiles [Time Frame: Week 12]

Change in serum inflammatory cytokines levels [Time Frame: Week 12]

Change in gut microbiome [Time Frame: Week 12]

Change in fatigue symptoms [Time Frame: Week 4 and Week 12]

Secondary ID(s)

2017P001489

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Winclove Bio Industries BV