NCT03266484.

Trial name or 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
Methods	A randomised, double‐blind, placebo‐controlled trial
Participants	100 adults (aged 18 ‐ 75 years) with a confirmed diagnosis of CD, UC or IBD‐unspecified, quiescent disease and persistent ongoing fatigue symptoms
Interventions	Experiment: Probiotic mixture taken twice a day for 12 weeks. Comparator: Placebo
Outcomes	Primary outcomes: Gut microbiome (16sRNA sequencing at week 12) Serum inflammatory cytokines levels (Biosciences Cytometric Bead Array kits at week 12) Metabolomic profiles (quantitative and semi‐quantitative gas chromatography‐mass spectrometry and liquid chromatography‐mass spectrometry methods at week 12) Fatigue (FACIT‐F at week 4 and week 12)
Starting date	November 2017
Contact information	Principal Investigator: Ashwin Ananthakrishnan Assistant Professor of Medicine, Massachusetts General Hospital Contact: Nynke Borren, MD 617‐726‐1997 nborrent@mgh.harvard.edu Contact Christine Wong 617‐724‐7559 cywong4@mgh.harvard.edu
Notes	Estimated study completion date: December 2019 Estimated enrollment: 100 participants