Trial reportPloS one2020
Fecal microbiota transplantation in systemic sclerosis: A double-blind, placebo-controlled randomized pilot trial.
Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 4 syntheses or guidelines pooled it, 68 citations in OpenAlex.
- The Relationship Between Microbiota, Nutrition, and Gastrointestinal Tract Symptoms in Patients with Systemic Sclerosis: A Systematic Review of the Literature.International journal of molecular sciences · 2025Pooled it
- Pooled it
- Encyclopedia of fecal microbiota transplantation: a review of effectiveness in the treatment of 85 diseases.Chinese medical journal · 2022Pooled it
- Safety and efficacy of fecal microbiota transplantation for autoimmune diseases and autoinflammatory diseases: A systematic review and meta-analysis.Frontiers in immunology · 2022Pooled it
- Cellular Players in Gastrointestinal Involvement of Systemic Sclerosis: Insights into Pathogenesis.Cells · 2025Review
- Advancing Gastrointestinal Microbiota Research in Systemic Sclerosis: Lessons Learned from Prior Research and Opportunities to Accelerate Discovery.Rheumatic diseases clinics of North America · 2025Review
- Systemic sclerosis-related fecal incontinence: a scoping review focusing on a neglected manifestation.Rheumatology (Oxford, England) · 2025Article
- Fecal microbiota transplantation-current perspective on human health.Frontiers in medicine · 2025Review
- Capsule robots for the monitoring, diagnosis, and treatment of intestinal diseases.Materials today. Bio · 2024Review
- Article
- Managing gastrointestinal manifestations in systemic sclerosis, a mechanistic approach.Expert review of clinical immunology · 2024Review
- Impact of the gut microbiome on skin fibrosis: a Mendelian randomization study.Frontiers in medicine · 2024Article
- The mechanism of gut-lung axis in pulmonary fibrosis.Frontiers in cellular and infection microbiology · 2024Review
- Effects of faecal microbiota transplantation on the small intestinal mucosa in systemic sclerosis.Rheumatology (Oxford, England) · 2023Article
- The Crosstalk between Gut Microbiota and Nervous System: A Bidirectional Interaction between Microorganisms and Metabolome.International journal of molecular sciences · 2023Review
- The Clinical Significance of Serum Biomarkers of the Intestinal Barrier in Systemic Sclerosis: A Cross-Sectional Study.Journal of personalized medicine · 2023Article
- Role of oral and gut microbiota in childhood obesity.Folia microbiologica · 2023Review
- Is there a role for the microbiome in systemic sclerosis?Expert review of clinical immunology · 2023Article
- Systemic sclerosis gastrointestinal dysmotility: risk factors, pathophysiology, diagnosis and management.Nature reviews. Rheumatology · 2023Review
- Bacterial Metabolites: A Link between Gut Microbiota and Dermatological Diseases.International journal of molecular sciences · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesSystemic 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.
methodsTen 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.
resultsACHIM 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.
conclusionsFMT of commercially-available ACHIM is associated with gastroduodenoscopy complications but reduces lower GI symptoms by possibly altering the gut microbiota in patients with SSc.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.