Fecal microbiota transplantation in systemic sclerosis: A double-blind, placebo-controlled randomized pilot trial

Håvard Fretheim, Brian K Chung, Henriette Didriksen, Espen S Bækkevold, Øyvind Midtvedt, Cathrine Brunborg, Kristian Holm, Jørgen Valeur, Anders Heiervang Tennøe, Torhild Garen, Tore Midtvedt, Marius Trøseid, Hasse Zarè, May Brit Lund, Johannes R Hov, Knut E A Lundin, Øyvind Molberg and Anna-Maria Hoffmann-Vold

PLOS ONE, 2020, vol. 15, issue 5, 1-14

Abstract: Objectives: Systemic sclerosis (SSc) is an auto-immune, multi organ disease marked by severe gastrointestinal (GI) involvement and gut dysbiosis. Here, we aimed to determine the safety and efficacy of fecal microbiota transplantation (FMT) using commercially-available anaerobic cultivated human intestinal microbiota (ACHIM) in SSc. Methods: Ten patients with SSc were randomized to ACHIM (n = 5) or placebo (n = 5) in a double-blind, placebo-controlled 16-week pilot. All patients had mild to severe upper and lower GI symptoms including diarrhea, distention/bloating and/or fecal incontinence at baseline. Gastroduodenoscopy transfer of ACHIM or placebo was performed at weeks 0 and 2. Primary endpoints were safety and clinical efficacy on GI symptoms assessed at weeks 4 and 16. Secondary endpoints included changes in relative abundance of total, immunoglobulin (Ig) A- and IgM-coated fecal bacteria measured by 16s rRNA sequencing. Results: ACHIM side effects were mild and transient. Two placebo controls experienced procedure-related serious adverse events; one developed laryngospasms at week 0 gastroduodenoscopy necessitating study exclusion whilst one encountered duodenal perforation during gastroduodenoscopy at the last study visit (week 16). Decreased bloating, diarrhea and/or fecal incontinence was observed in four of five patients in the FMT group (week 4 or/and 16) and in two of four in the placebo group (week 4 or 16). Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated more after FMT, than after placebo. Conclusions: FMT of commercially-available ACHIM is associated with gastroduodenoscopy complications but reduces lower GI symptoms by possibly altering the gut microbiota in patients with SSc.

Date: 2020
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0232739

DOI: 10.1371/journal.pone.0232739

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