1. Fecal microbiota transplantation in systemic sclerosis: A double-blind, placebo-controlled randomized pilot trial
- Author
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Øyvind Midtvedt, Tore Midtvedt, Espen S. Baekkevold, Knut E.A. Lundin, Torhild Garen, May Brit Lund, Håvard Fretheim, Jørgen Valeur, Johannes R. Hov, Øyvind Molberg, Marius Trøseid, Anders Heiervang Tennøe, Anna-Maria Hoffmann-Vold, Kristian Holm, Brian K Chung, Cathrine Brunborg, Hasse Khiabani Zare, and Henriette Didriksen
- Subjects
Male ,Pilot Projects ,Gut flora ,Pathology and Laboratory Medicine ,Gastroenterology ,law.invention ,Placebos ,Feces ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine and Health Sciences ,Fecal incontinence ,030212 general & internal medicine ,Materials ,Multidisciplinary ,biology ,Fatty Acids ,Genomics ,Fecal Microbiota Transplantation ,Middle Aged ,Diarrhea ,Treatment Outcome ,Medical Microbiology ,Research Design ,Physical Sciences ,Medicine ,Engineering and Technology ,Female ,030211 gastroenterology & hepatology ,medicine.symptom ,Anaerobic exercise ,Research Article ,medicine.medical_specialty ,Clinical Research Design ,Science ,Urology ,Materials Science ,Microbial Genomics ,Gastroenterology and Hepatology ,Research and Analysis Methods ,Placebo ,Microbiology ,03 medical and health sciences ,Signs and Symptoms ,Bloating ,Double-Blind Method ,Diagnostic Medicine ,Coatings ,Internal medicine ,Genetics ,medicine ,Humans ,Adverse effect ,Incontinence ,Scleroderma, Systemic ,Bacteria ,Surface Treatments ,business.industry ,Gut Bacteria ,Organisms ,Biology and Life Sciences ,Pilot Studies ,biology.organism_classification ,Immunoglobulin A ,Immunoglobulin M ,Manufacturing Processes ,Microbiome ,Adverse Events ,business ,Leukocyte L1 Antigen Complex ,Fecal Incontinence - 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.
- Published
- 2020
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