Budesonide does not affect engraftment, clinical response after FMT in ulcerative colitis
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Key takeaways:
- Use of budesonide before FMT did not increase donor microbiota engraftment or clinical response.
- Differences in taxonomic composition of donors were linked to clinical response.
Pretreatment with budesonide did not significantly influence engraftment among patients with ulcerative colitis who underwent fecal microbiota transplantation, with researchers reporting that clinical response appeared to be donor-dependent.
“Several studies addressed the effects of FMT for UC, showing a response rate of around 36% for patients with various treatment regimens,” Emilie van Lingen, MD, of the department of gastroenterology and hepatology at Leiden University Medical Center, and colleagues wrote in the Journal of Crohn’s and Colitis. “Of note, efficacy may be donor-dependent and response appears associated with engraftment of the donor microbiota.
“These previous studies highlight many unanswered questions about treatment of UC patients with FMT; how to identify preferred donors and determine which pretreatments promote donor microbiome and response.”
In a single-center, double-blind, randomized controlled trial, researchers investigated the effect of FMT after pretreatment with budesonide or placebo among 24 adult patients (median age, 42 years; 50% men) with active mild to moderate UC. Researchers also assessed clinical response at weeks 10 and 14 based on partial and full Mayo scores, respectively.
Patients received 3 weeks of budesonide 9 mg (n = 13) or placebo (n = 11) followed by four weekly infusions of donor feces suspension. Based on microbiota composition, researchers chose stool samples from two donors.
At baseline, median disease duration was 13.5 years, median full Mayo score was 7 and median fecal calprotectin was 944 µg/g.
Results showed pretreatment with budesonide did not increase donor microbiota engraftment or clinical response vs. placebo. At week 10, 42% of all patients achieved clinical remission, 8% achieved partial remission and 50% demonstrated no clinical response or progressive symptoms. Pretreatment with budesonide was associated with a nonsignificant higher response rate compared with placebo (8 vs. 4 patients) and donor randomization did not influence Mayo score.
At week 14, 38% of patients achieved combined clinical and endoscopic remission, 4% achieved partial remission and 58% had no response. At this timepoint, researchers also reported a donor-dependent effect, whereby FMT suspensions from one donor were associated with clinical response (80% vs. 20% of responders), although patients treated with this suspension had decreased overall engraftment of donor microbiota.
Further, researchers found that an abundance of Clostridia clusters IV and XIVa, such as Rosebuira and Dorea, or Bacteroidales, including Bacteroides and Coprobacter, among donors was “highly predictive” of clinical response.
“Pretreatment with 3 weeks budesonide did not significantly influence engraftment of donor microbiota and engraftment was not associated with clinical outcome,” van Lingen and colleagues wrote. “However, a significant donor-dependent effect of FMT in ulcerative colitis was seen, where caution is advised when interpretating these results, with the small number of patients included.”
They continued: “Interestingly, patients treated with FMT suspensions from the donor that was associated with clinical response had lower engraftment, suggesting that response might be related to specific microorganisms instead of overall engraftment.”
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