Trial reportPloS one2018
Safety and preliminary efficacy of orally administered lyophilized fecal microbiota product compared with frozen product given by enema for recurrent Clostridium difficile infection: A randomized clinical trial.
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02449174 (A Study of Fecal Microbiota Transplantation), which is not on this map. Cited by 77 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.
A Study of Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent C. Difficile Associated Diarrhea (RCDAD) Via Retention Enema or Oral Route
Who cites it
77 citing papers in PubMed, 4 syntheses or guidelines pooled it, 123 citations in OpenAlex.
- Efficacy and safety of fecal microbiota transplantation in the management of parkinson's disease: a systematic review.BMC neurology · 2025Pooled it
- Comparative effectiveness of treatments for recurrentFrontiers in pharmacology · 2024Pooled it
- Fecal microbiota transplantation for the treatment of recurrent Clostridioides difficile (Clostridium difficile).The Cochrane database of systematic reviews · 2023Pooled it
- Fecal microbiota transplantation in irritable bowel syndrome: A systematic review and meta-analysis.United European gastroenterology journal · 2019Pooled it
- Feasibility and efficacy of fecal microbiota transplantation in adolescents with refractory irritable bowel syndrome: A randomized clinical pilot trial.Journal of pediatric gastroenterology and nutrition · 2026Trial
- Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study.BMC gastroenterology · 2021Trial
- Article
- Transplantation of encapsulated fecal microbiota: research progress and future trends.World journal of pediatrics : WJP · 2026Review
- Randomized, double-blind, placebo-controlled trial of fecal microbiota transplantation from young physically active donors to promote resilient aging: clinical trial protocol (ARMOR study).BMC geriatrics · 2026Article
- Gut microbiota in obesity management: from microbial clocks to precision microbial therapies.Frontiers in cellular and infection microbiology · 2026Review
- Advances in capsule-based fecal microbiota transplantation: clinical applications and innovations.Journal of translational medicine · 2025Review
- Microbiota transplant therapy in inflammatory bowel disease: advances and mechanistic insights.Gut microbes · 2025Review
- Assessing live microbial therapeutic transmission.Gut microbes · 2025Review
- Evaluation of the effects of different formulations of protectants on the preservation of the microbiota in fecal microbiota transplantation.International microbiology : the official journal of the Spanish Society for Microbiology · 2025Article
- In vitro validation concept for lyophilized fecal microbiota products with a focus on bacterial viability.World journal of microbiology & biotechnology · 2025Article
- Comparative effectiveness of different therapies forThe Lancet regional health. Europe · 2025Article
- Management of Recurrent Clostridioides difficile Infection (rCDI): A Systematic Literature Review to Assess the Feasibility of Indirect Treatment Comparison (ITC).Infectious diseases and therapy · 2025Review
- Article
- Article
- Validation methods for encapsulated faecal microbiota transplantation: a scoping review.Therapeutic advances in gastroenterology · 2025Review
17 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundFecal microbiota transplantation (FMT) via colonoscopy or enema has become a commonly used treatment of recurrent C. difficile infection (CDI).
aimsTo compare the safety and preliminary efficacy of orally administered lyophilized microbiota product compared with frozen product by enema.
methodsIn a single center, adults with ≥ 3 episodes of recurrent CDI were randomized to receive encapsulated lyophilized fecal microbiota from 100-200 g of donor feces (n = 31) or frozen FMT from 100 g of donor feces (n = 34) by enema. Safety during the three months post FMT was the primary study objective. Prevention of CDI recurrence during the 60 days after FMT was a secondary objective. Fecal microbiome changes were examined in first 39 subjects studied.
resultsAdverse experiences were commonly seen in equal frequency in both groups and did not appear to relate to the route of delivery of FMT. CDI recurrence was prevented in 26 of 31 (84%) subjects randomized to capsules and in 30 of 34 (88%) receiving FMT by enema (p = 0.76). Both products normalized fecal microbiota diversity while the lyophilized orally administered product was less effective in repleting Bacteroidia and Verrucomicrobia classes compared to frozen product via enema.
conclusionsThe route of delivery, oral or rectal, did not influence adverse experiences in FMT. In preliminary evaluation, both routes appeared to show equivalent efficacy, although the dose may need to be higher for lyophilized product. Spore-forming bacteria appear to be the most important engrafting organisms in FMT by the oral route using lyophilized product.
trial registrationClinicalTrials.gov NCT02449174.
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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.