Fecal material transplantation for the management of patients with IBD demonstrates a response rate of 53.8% with a complete remission of 37%.
Findings of a recent analysis indicated frozen fecal material from universal donors may be related to a higher rate of clinical remission among patients with inflammatory bowel disease (IBD), especially for Crohn disease.
The results produced positive evidence of the use of frozen fecal material.
Luciane de Fatima Caldeira, MS, and colleagues conducted a systematic review and meta-analysis to gather evidence on the efficacy and safety of fecal microbiota transplantation for IBD. They conducted searches in PubMed, Scopus, and Web of Science databases. The team searched for phrases including fecal microbiota transplantation, fecal microbiota, foecal microbiota, and faecal microbiota. Studies evaluated the efficacy/effectiveness or safety of fecal microbiota transplantation in patients of any age or gender diagnosed with IBD, with or without a treatment comparator and reporting response, remission, or adverse events.
Members of the team screened the titles and abstracts to identify irrelevant records. They used a standardized form to collect data on the general characteristics and clinical outcomes of the included studies.
The investigators included 60 studies for the qualitative synthesis and 36 were able to be used in the quantitative synthesis. The mean Newcastle-Ottawa Scale score for the quasi-experimental studies was 6 (range, 6-8).
The team noted 6 of 9 randomized controlled trials presented comparable data and were assessed in 2 meta-analyses—1 for clinical remission and 1 for clinical response. There were statistically significant differences observed for both outcomes, favoring fecal microbiota transplantation over placebo (355 patients, clinical remission: RR, 1.7 [95% CI, 1.12-2.56], I2=45%; clinical response: RR, 1.68 [95% CI, 1.04-2.72], I2=55%).
Overall, 24 quasi-experimental studies assessed clinical remission. An analysis resulted in a clinical remission prevalence of 32.3% (95% CI, 23.1-43.1), while the 9 randomized controlled trials resulted in a rate of 46% (95% CI, 31.4-61.4). There was an overall remission rate of 37% (95% CI, 28.8-45.9) and there was no significant difference between the 2 study designs (P=.144).
In a stool type subgroup analysis, the clinical remission rate for fresh fecal material was 29.1%, while rates were 44.2% for frozen fecal matter, 57.2% when both types of stool were used, and 66.5% for capsules, with a statistical difference observed among the groups (P=.036).Patients who had Crohn disease presented a remission rate of 47.6% and those with ulcerative colitis demonstrated a remission rate of 35%.
For clinical response, 26 quasi-experimental studies and 7 randomized controlled trials resulted in a response of 53.5% and 54.4%, respectively. Those who received fresh fecal material had a clinical response of 52.1%, while patients who received frozen fecal material presented a response of 52.8%. If fecal material was received from relatives or acquaintances, the pooled clinical response was 37.1%. Those who received fecal material from universal donors had a response rate of 59.7%.
There was a frequency of 26.9% and 48.2% for adverse events among the quasi-experimental studies and randomized controlled trials, respectively. Among studies where fresh fecal material was transplanted, the frequency of any adverse event was 30.2%, while it was 43.2% among studies using frozen fecal material and 22.6% in those using capsules.
The investigators found fecal material transplantation for the management of patients with IBD demonstrated a response rate of 53.8% with a complete remission of 37%.
The study, “Fecal microbiota transplantation in inflammatory bowel disease patients: A systematic review and meta-analysis,” was published online in PLOS One.