Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis

Rapoport, Eliot; Baig, Muhammad A.; Puli, Srinivas R.

doi:10.20524/aog.2022.0695

Cited by 20 publications

(13 citation statements)

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“…No treatment-related serious TEAEs or deaths were reported. The favorable tolerability profile of VE303 was expected, based on prior reports of fecal microbiota transplants and other live biotherapeutic products …”

Section: Discussionmentioning

confidence: 90%

VE303, a Defined Bacterial Consortium, for Prevention of Recurrent Clostridioides difficile Infection

Louie

Golan

Khanna

et al. 2023

JAMA

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ImportanceThe effect of rationally defined nonpathogenic, nontoxigenic, commensal strains of Clostridia on prevention of Clostridioides difficile infection (CDI) is unknown.ObjectiveTo determine the efficacy of VE303, a defined bacterial consortium of 8 strains of commensal Clostridia, in adults at high risk for CDI recurrence. The primary objective was to determine the recommended VE303 dosing for a phase 3 trial.Design, Setting, and ParticipantsPhase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted from February 2019 to September 2021 at 27 sites in the US and Canada. The study included 79 participants aged 18 years or older who were diagnosed with laboratory-confirmed CDI with 1 or more prior CDI episodes in the last 6 months and those with primary CDI at high risk for recurrence (defined as aged ≥75 years or ≥65 years with ≥1 risk factors: creatinine clearance &lt;60 mL/min/1.73 m2, proton pump inhibitor use, remote [&gt;6 months earlier] CDI history).InterventionsParticipants were randomly assigned to high-dose VE303 (8.0 × 109 colony-forming units [CFUs]) (n = 30), low-dose VE303 (1.6 × 109 CFUs) (n = 27), or placebo capsules (n = 22) orally once daily for 14 days.Main Outcomes and MeasuresThe primary efficacy end point was the proportion of participants with CDI recurrence at 8 weeks using a combined clinical and laboratory definition. The primary efficacy end point was analyzed in 3 prespecified analyses, using successively broader definitions for an on-study CDI recurrence: (1) diarrhea consistent with CDI plus a toxin-positive stool sample; (2) diarrhea consistent with CDI plus a toxin-positive, polymerase chain reaction–positive, or toxigenic culture–positive stool sample; and (3) diarrhea consistent with CDI plus laboratory confirmation or (in the absence of a stool sample) treatment with a CDI-targeted antibiotic.ResultsBaseline characteristics were similar across the high-dose VE303 (n = 29; 1 additional participant excluded from efficacy analysis), low-dose VE303 (n = 27), and placebo (n = 22) groups. The participants’ median age was 63.5 years (range, 24-96); 70.5% were female; and 1.3% were Asian, 1.3% Black, 2.6% Hispanic, and 96.2% White. CDI recurrence rates through week 8 (using the efficacy analysis 3 definition) were 13.8% (4/29) for high-dose VE303, 37.0% (10/27) for low-dose VE303, and 45.5% (10/22) for placebo (P = .006, high-dose VE303 vs placebo).Conclusions and RelevanceAmong adults with laboratory-confirmed CDI with 1 or more prior CDI episodes in the last 6 months and those with primary CDI at high risk for recurrence, high-dose VE303 prevented recurrent CDI compared with placebo. A larger, phase 3 study is needed to confirm these findings.Trial RegistrationClinicalTrials.gov Identifier: NCT03788434

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Section: Discussionmentioning

confidence: 90%

VE303, a Defined Bacterial Consortium, for Prevention of Recurrent Clostridioides difficile Infection

Louie

Golan

Khanna

et al. 2023

JAMA

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“…Este caso muestra que el TMF puede ser una técnica segura y eficaz en el tratamiento de la ICD recurrente en este grupo de pacientes. Un metaanálisis que incluyó 61 estudios (5.099 pacientes), mostró que el TMF es una técnica segura con escasos eventos adversos, generalmente leve a moderados y autolimitados 14 . La ausencia de eventos adversos en nuestro paciente post-TMF muestra que esta es una estrategia válida en pacientes mayores de 65 años, tal como ha sido señalado en otra publicación nacional 13 .…”

Section: Discussionunclassified

Trasplante de microbiota fecal por colonoscopía en paciente mayor de 65 años con infección recurrente de Clostridioides difficile: aún una estrategia subutilizada

et al. 2022

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Fecal microbiota transplantation in an older patient with Clostridioides difficile recurrent infection. Report of one caseClostridioides difficile infection (CDI) is a major public health problem and responsible for significant morbidity and mortality. Eighty percent of CDIs occur in adults older than 65 years of age due to a decreased gastrointestinal microbial diversity, immunosenescence and frailty. Thus, the most reported risk factor for recurrent CDI is older age since nearly 60% of cases occur in individuals aged ≥ 65 years. Fecal microbiota transplantation (FMT) is a highly cost-effective alternative to antibiotic treatment for patients with recurrent CDI. We report a 75-year-old male with recurrent CDI, who received a FMT after several unsuccessful antimicrobial treatments. He had a satisfactory evolution after the procedure and remained without diarrhea during the ensuing five months.

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“…In patients with CDI receiving FMT, an earlier meta-analysis found overall disease recurrence rates of 5.5% (95% CI, 2.2-10.3%), with early (<90 days) recurrence of 2.9% (95% CI, 0.009-0.058%) and late (≥90 days) recurrence of 1.7% (95% CI, 0.4-4.2%; Figure 10A). Total severe adverse events were 0.65% (95% CI, 0.45-0.89%; Supplementary Table S2; Rapoport et al, 2022). Antibiotic use was associated with most recurrences.…”

Section: Disease Recurrence and Safetymentioning

confidence: 99%

The gut microbiome dysbiosis and regulation by fecal microbiota transplantation: umbrella review

Zhang,

Luo,

Tian

et al. 2023

Front. Microbiol.

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BackgroundGut microbiome dysbiosis has been implicated in various gastrointestinal and extra-gastrointestinal diseases, but evidence on the efficacy and safety of fecal microbiota transplantation (FMT) for therapeutic indications remains unclear.MethodsThe gutMDisorder database was used to summarize the associations between gut microbiome dysbiosis and diseases. We performed an umbrella review of published meta-analyses to determine the evidence synthesis on the efficacy and safety of FMT in treating various diseases. Our study was registered in PROSPERO (CRD42022301226).ResultsGut microbiome dysbiosis was associated with 117 gastrointestinal and extra-gastrointestinal. Colorectal cancer was associated with 92 dysbiosis. Dysbiosis involving Firmicutes (phylum) was associated with 34 diseases. We identified 62 published meta-analyses of FMT. FMT was found to be effective for 13 diseases, with a 95.56% cure rate (95% CI: 93.88–97.05%) for recurrent Chloridoids difficile infection (rCDI). Evidence was high quality for rCDI and moderate to high quality for ulcerative colitis and Crohn’s disease but low to very low quality for other diseases.ConclusionGut microbiome dysbiosis may be implicated in numerous diseases. Substantial evidence suggests FMT improves clinical outcomes for certain indications, but evidence quality varies greatly depending on the specific indication, route of administration, frequency of instillation, fecal preparation, and donor type. This variability should inform clinical, policy, and implementation decisions regarding FMT.

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Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis

Cited by 20 publications

References 54 publications

VE303, a Defined Bacterial Consortium, for Prevention of Recurrent Clostridioides difficile Infection

VE303, a Defined Bacterial Consortium, for Prevention of Recurrent Clostridioides difficile Infection

Trasplante de microbiota fecal por colonoscopía en paciente mayor de 65 años con infección recurrente de Clostridioides difficile: aún una estrategia subutilizada

The gut microbiome dysbiosis and regulation by fecal microbiota transplantation: umbrella review

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