Fecal microbiota transplantation in systemic sclerosis: A double-blind, placebo-controlled randomized pilot trial
| Autor: | 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, Henriette Didriksen |
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| Rok vydání: | 2020 |
| Předmět: |
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 |
| Zdroj: | PLoS ONE PLoS ONE, Vol 15, Iss 5, p e0232739 (2020) |
| ISSN: | 1932-6203 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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