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Lyophilised oral faecal microbiota transplantation for ulcerative colitis (LOTUS): a randomised, double-blind, placebo-controlled trial
Abstract
Background Faecal microbiota transplantation (FMT) delivered via colonoscopic infusion or enemas have been shown to induce remission in a proportion of patients with active ulcerative colitis. Whether orally administered FMT is effective in ulcerative colitis is unknown. We aimed to assess the efficacy of oral lyophilised FMT for the treatment of active ulcerative colitis. Methods A double-blind, randomised, placebo-controlled trial was conducted at two centres in Australia. Eligible patients were aged 18-75 years with active ulcerative colitis (defined as clinical and endoscopic active ulcerative colitis, with a total Mayo score of 4-10, and a Mayo endoscopic subscore ≥1). After 2 weeks of amoxicillin, metronidazole, and doxycycline, patients were randomly assigned in a 1:1 ratio to receive either oral lyophilised FMT or placebo capsules for 8 weeks, using a prespecified computer-generated randomisation list with a permuted block size of 8. The primary outcome was corticosteroid-free clinical remission with endoscopic remission or response (total Mayo score ≤2, all subscores ≤1, and ≥1 point reduction in endoscopic subscore) at week 8. At week 8, FMT responders were randomly assigned (in a 1:1 ratio, permuted block size of 8) to either continue or withdraw FMT for a further 48 weeks. Analyses were done by modified intention-to-treat, including all patients who received at least one study dose. This trial is registered with Australian New Zealand Trial Registry, number ACTRN…
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“Capsulized FMT is sustainable in the long-term, especially in its lyophilized form, 98”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [98]
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“As described in this review, there is emerging evidence that FMT may act as a chronic therapy. 98”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [98]
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Metadata
- Authors
- Haifer, C., Paramsothy, S., Kaakoush, N. O., Saikal, A., Ghaly, S., Yang, T., Luu, L. D. W., Borody, T. J., & Leong, R. W.
- Affiliations
- The University of Sydney (AU)
- UNSW Sydney (AU)
- Centre For Digestive Diseases (AU)
- Corresponding author
- Leong, Rupert W
- ORCID
- Venue
- The Lancet Gastroenterology & Hepatology
- Publisher
- Elsevier BV
- Published
- 2022-02
- Volume
- 7
- Issue
- 2
- Pages
- 141-151
- ISSN
- 2468-1156 (ISSN-L)
- 2468-1253
- OpenAlex
- W3215433280
- Cited by
- 285
- References
- 30
- Citations by year
- 2026: 45 · 2025: 79 · 2024: 60 · 2023: 68 · 2022: 32
- FWCI
- 22.76
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- The Lancet. Gastroenterology & hepatology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Gastroenterological Society of Australia
- Topics
- Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Microscopic Colitis
- Keywords
- fecal microbiota transplantation, ulcerative colitis, corticosteroid-free remission, endoscopic remission, treatment withdrawal, COVID-19 pandemic, inflammatory bowel disease, antibiotic pretreatment, clinical remission, endoscopic response, safety and tolerability
- MeSH terms
- Fecal Microbiota Transplantation, Administration, Oral, Adult, Anti-Bacterial Agents, Colitis, Ulcerative, Double-Blind Method, Female, Freeze Drying, Humans, Male, Middle Aged, Remission Induction
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