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Updated: May 24, 2025

Therapeutic Evaluation of Fecal Microbiota Transplantation in an Interleukin 10-Deficient Mouse Model
Published on: April 6, 2022
Fecal Microbiota Transplantation (FMT) and Clinical Outcomes Among Inflammatory Bowel Disease (IBD) Patients: An
Sheza Malik1, Syed Arsalan Ahmed Naqvi2, Abul Hasan Shadali3
1Internal Medicine, Rochester General Hospital, Rochester, NY, USA.
Background And Aims:
Recent systematic reviews and meta-analyses (SRMAs) have shown inconsistent effectiveness of FMT among patients with IBD. This study aimed to appraise the evidence for clinically relevant outcomes with FMT in patients with IBD using published SRMAs.
Methods:
We searched major databases from inception through Nov 2023 to identify SRMAs assessing the effectiveness of FMT in patients with IBD. Primary outcomes included clinical remission, clinical response, endoscopic remission/response, a composite endpoint, and adverse effects. We included SRMAs investigating FMT's effect in patients with IBD using RCTs and observational studies data. Methodological quality and evidence certainty were assessed using AMSTAR 2 and GRADE.
Results:
Out of 106 citations, 16 SRMAs were included with varying study sizes (2 to 60 primary studies) and participants (112 to 1169 per SRMA). Five SRMAs assessed FMT in IBD, while 11 focused on Ulcerative Colitis (UC). Seven SRMAs included RCTs only, and nine included both RCTs and observational studies. Methodological quality was critically low in 9 SRMAs (56%) and low in 7 studies (44%). FMT showed clinical remission benefit in all 16 SRMAs, with varying certainty: 3 high, 4 moderate, 4 low, and 5 very low. Endoscopic remission/response was reported in 5 meta-analyses on UC, with 1 high, 3 moderate, and 1 very low certainty. Combined clinical remission and endoscopic response were reported in 3 SRMAs on UC, with 1 low and 2 moderate certainty. Adverse events were reported in 6 SRMAs, with 1 high, 3 moderate, 1 low, and 1 very low certainty.
Conclusion:
Current evidence shows potential benefits of FMT in IBD, particularly UC, supported by significant associations in 16 meta-analyses. However, poor methodological quality and variability in evidence certainty call for high-quality RCTs to strengthen the evidence.
Insights
Fecal microbiota transplantation (FMT) shows potential benefits for inflammatory bowel disease (IBD), especially ulcerative colitis (UC). However, the low quality of current evidence necessitates more high-quality randomized controlled trials (RCTs).
Area of Science:
- Gastroenterology
- Microbiome Research
- Clinical Evidence Synthesis
Background:
- Systematic reviews and meta-analyses (SRMAs) report inconsistent effectiveness of fecal microbiota transplantation (FMT) for patients with inflammatory bowel disease (IBD).
- Appraising existing evidence is crucial to understand FMT's true impact on IBD outcomes.
Purpose of the Study:
- To critically evaluate the evidence for clinically relevant outcomes of FMT in IBD patients using published SRMAs.
- To assess the quality and certainty of evidence for FMT's efficacy and safety in IBD.
Main Methods:
- A comprehensive search of major databases identified SRMAs published up to November 2023.
- Included SRMAs assessed FMT effectiveness in IBD using data from randomized controlled trials (RCTs) and observational studies.
- Methodological quality and evidence certainty were evaluated using AMSTAR 2 and GRADE criteria.
Main Results:
- Sixteen SRMAs were included, with varying methodologies and participant numbers; 5 focused on IBD and 11 on ulcerative colitis (UC).
- Methodological quality was predominantly low (56% critically low, 44% low).
- FMT demonstrated a clinical remission benefit across all 16 SRMAs, though evidence certainty varied (3 high, 4 moderate, 4 low, 5 very low). Similar benefits were noted for endoscopic outcomes and adverse events, particularly in UC.
Conclusions:
- Current evidence suggests potential benefits of FMT for IBD, particularly UC, as indicated by significant associations in 16 meta-analyses.
- The overall low methodological quality and variable evidence certainty highlight the need for rigorous, high-quality RCTs to confirm these findings.
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