Frederik Cold (1,2,3), Stig Gunther(1), Sofie I Halkjær(3), Patrick D Browne (2), Andreas M Petersen (3), Zahra Al-Gibouri (3), Lars H Hansen (2) and Alice H Christensen (1)

Affiliates

(1) Department of Gastroenterology, Aleris-Hamlet Hospitals Copenhagen, Søborg, Denmark (2) Department of Environmental Science, Aarhus University, Roskilde, Denmark (3) Department of Gastroenterology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark

Abstract

Background:
Growing evidence indicates that gut ’dysbiosis’ is a factor in the pathogenesis of Inflammatory Bowel Disease (IBD).
Fecal Microbiota Transplantation (FMT) appears to be promising in Ulcerative Colitis remission induction.

Methods:
Seven patients, aged between 27 to 51 years, with active Ulcerative Colitis (UC), were treated with 25 multi-donor FMT capsules daily for 50 days as a supplement to their standard treatment.
Participants were followed with fecal samples, Inflammatory Bowel Disease Questionnaire (IBDQ) and Simple Clinical Colitis Activity Index (SCCAI) at regular visits for six months.
Mann-Whitney U tests were used to compare F-Calprotectin, IBDQ and SCAAI levels at each time-point after baseline with the levels at baseline.

Results:
From a median SCAAI of 6 at baseline, the SCCAI of all participants decreased, with median decreases of 5 (p = 0.001) and 6 (p = 0.001) after 4 and 8 weeks, respectively.
The median F-Calprotectin at baseline was ≥1800 mg/kg. This decreased significantly during the treatment period, but increased in the follow-up period.
The median IBDQ increased at all visits compared to baseline.
The fecal microbiota α-diversity did not increase in the study period compared to baseline.
All participants completed the treatment and no serious adverse events were reported.
Three of the seven patients had flare-up/relapse of symptoms after the active treatment period.

Conclusion
50 days of daily multi-donor FMT-capsules were safe and significantly improved symptoms and health related life quality and decreased F-Calprotectin in the active treatment period in patients with active UC.