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

PLoS One. 2020 May 21;15(5):e0232739. doi: 10.1371/journal.pone.0232739. eCollection 2020.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bacteria
  • Double-Blind Method
  • Fatty Acids / metabolism
  • Fecal Incontinence / etiology
  • Fecal Microbiota Transplantation* / adverse effects
  • Feces / chemistry
  • Female
  • Humans
  • Immunoglobulin A / metabolism
  • Immunoglobulin M / metabolism
  • Leukocyte L1 Antigen Complex / metabolism
  • Male
  • Middle Aged
  • Pilot Projects
  • Placebos
  • Scleroderma, Systemic / microbiology*
  • Scleroderma, Systemic / therapy*
  • Treatment Outcome


  • Fatty Acids
  • Immunoglobulin A
  • Immunoglobulin M
  • Leukocyte L1 Antigen Complex
  • Placebos

Grant support

This work was supported by grants from the Norwegian Women’s Public Health Association and the South-Eastern Norway Regional Health Authority. The funding sources were not involved in any part of the study design, collection of data, analysis, interpretation or writing of the report.