Trial reportCanadian journal of psychiatry. Revue canadienne de psychiatrie2023
Feasibility, Acceptability, and Safety of Faecal Microbiota Transplantation in the Treatment of Major Depressive Disorder: A Pilot Randomized Controlled Trial.
Trial report in Canadian journal of psychiatry. Revue canadienne de psychiatrie, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis 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
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.
- Clinical efficacy of fecal microbiota transplantation in alleviating depressive symptoms: a meta-analysis of randomized trials.Frontiers in psychiatry · 2025Pooled it
- The Safety, Efficacy, and Feasibility of Fecal Microbiota Transplantation in a Population With Bipolar Disorder During Depressive Episodes: A Pilot Parallel Arm Randomized Controlled Trial: Sécurité, efficacité et faisabilité de la transplantation de microbiote fécal chez une population atteinte de troubles bipolaires, au cours d'épisodes dépressifs : essai pilote contrôlé à répartition aléatoire et à groupes parallèles.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2026Trial
- Encapsulated faecal microbiota transfer in young women with anorexia nervosa: an open-label feasibility pilot trial.Nature communications · 2025Trial
- PROVIT-CLOCK: A Potential Influence of Probiotics and Vitamin B7 Add-On Treatment and Metabolites on Clock Gene Expression in Major Depression.Neuropsychobiology · 2024Trial
- Delivering the Gut to the Brain: Drug Delivery Strategies for Microbiota-Derived Therapeutics in Depression.Pharmaceutics · 2026Review
- Review
- Unraveling the gut microbiota-brain axis: Mechanisms, pathophysiology, and therapeutic opportunities.iScience · 2026Review
- Complex correlations between mitochondrial DNA variants and gut microbiome in major depressive disorder: a genome-wide association analysis.BMC psychiatry · 2026Article
- Probiotics as Modulators of Adult Neurogenesis and Synaptic Plasticity: New Perspectives in the Pathophysiology and Treatment of Affective Disorders.Biomedicines · 2026Review
- A human-derived Bacteroides strain attenuates depressive-like behavior in a rat model of social defeat-induced stress.BMC medicine · 2026Article
- Gut Microbiota Dysbiosis in Depression: Pathological Correlations, Molecular Pathways, and Therapeutic Interventions.International journal of molecular sciences · 2026Review
- Gut microbiota dysbiosis and depression: Bidirectional interactions, mediating pathways, and microecological therapeutics.Current research in food science · 2026Review
- Imbalance of the Brain-Gut-Microbiota Axis in Major Depressive Disorder: From Pathogenesis to Clinical Translation.Neuropsychiatric disease and treatment · 2026Review
- Brief Report: Can Fecal Microbiota Transplantation Treat Depression?JGH open : an open access journal of gastroenterology and hepatology · 2026Article
- Interplay between the gut microbiota and MAPK/NF-κ B/Nrf2 signaling in depression: pharmacological insights from traditional Chinese medicine.Frontiers in pharmacology · 2026Review
- Comment letter on 'gut microbiota, circadian rhythms and their interactions: implications for the pathogenesis and treatment of depression'.Annals of medicine · 2025Article
- Attenuating Neurotoxicity Through Fecal Microbiota Transplant: Mechanisms and Therapeutic Potential.Molecular neurobiology · 2025Review
- Gut: The gate and key to brain.Chinese medical journal · 2025Review
- Mechanism of Microbiota-Gut-Brain in Perimenopausal Depression: An Inflammatory Perspective.Expert reviews in molecular medicine · 2025Review
- Public knowledge, awareness and perception of gut microbiome and faecal microbiota transplantation in Singapore: a survey study.Singapore medical journal · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesPerturbations of the intestinal microbiota have been associated with mental health disorders, including major depressive disorder (MDD). Therefore, faecal microbiota transplantation (FMT) holds promise as a microbiota-modulating treatment for MDD. Yet, to date, there are no published controlled studies evaluating the use of FMT for MDD. This study aimed to address this gap by evaluating the feasibility, acceptability, and safety of FMT for MDD.
methodsThe study was an 8-week, double-blind, 2:1 parallel group, randomized controlled pilot trial (
resultsRecruitment was completed within 2 months, with 0% attrition and 100% attendance at key study appointments. There were no major protocol deviations. The placebo and blinding strategies were considered successful; nurses and participants correctly guessing their treatment allocation at a rate similar to that anticipated by chance. No serious or severe adverse events were reported in either group, and there were no significant differences in mild-to-moderate adverse events between groups (median of 2 adverse events per participant reported in both groups). Furthermore, the 12/15 participants who completed the Week 2 participant satisfaction survey agreed or strongly agreed that the enema delivery was tolerable and that they would have the treatment again if required. Whilst the study was not designed to measure clinical outcomes, exploratory data also suggested that the active FMT treatment may lead to improvements in gastrointestinal symptoms and quality of life in this population, noting that irritable bowel syndrome is commonly comorbid with MDD.
conclusionsAll feasibility targets were met or exceeded. This study found that enema-delivered FMT is feasible, acceptable, well-tolerated, and safe in patients with MDD. The findings of this study support further research to evaluate clinical efficacy, and the use of this protocol is supported.
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Registered trials
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.