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Fecal transplant no better than placebo for IBS-D
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Researchers cut a trial short after fecal microbiota transplantation failed to provide symptom relief better than that of placebo in patients with diarrhea-predominant irritable bowel syndrome.
Olga C. Aroniadis, MD, of the department of internal medicine at Montefiore Medical Center, and colleagues wrote in The Lancet Gastroenterology & Hepatology that previous studies have reported conflicting results for the efficacy of FMT for IBS. Two randomized controlled trials reported that patients experience significant improvement, while two others found no such benefit.
“We specifically chose to include only patients with IBS-D because FMT has been studied in diarrheal diseases, such as [Clostridioides difficile] infection and [inflammatory bowel disease], and also because we wanted to minimize heterogeneity in the study population,” they wrote. “We tested the hypothesis that FMT administration to patients with IBS-D would result in an improvement in symptoms compared with placebo.”
Researchers performed a double-blind, placebo-controlled crossover trial comprising 48 patients aged 18 to 65 years with moderate-to-severe IBS-D, defined as an IBS-Symptoms Severity Score (IBS-SSS) greater than 175. They randomly assigned patients to receive FMT capsules followed by identical placebo capsules (n = 25) or placebo followed by FMT (n = 23). After 12 weeks, patients were to switch to the alternate treatment. Three patients in the FMT-first group were lost to follow-up.
At baseline, patients in the FMT group had a mean IBS-SSS of 278 (standard deviation = 60), while patients in the placebo group had a mean score of 309 ( SD = 64).
Investigators made the decision to terminate the trial after interim results revealed that IBS-SSS did not differ between patients who received FMT (mean 221; SD =105) and those who received placebo (236; SD = 95) at 12 weeks after adjustment for baseline scores.
However, Aroniadis and colleagues found that FMT was safe with no serious adverse events reported in the FMT group. The most common drug-related adverse events were abdominal pain, nausea and exacerbation of diarrhea.
“Additional studies are needed to establish the efficacy of FMT for IBS-D and to improve the understanding of whether manipulation of the gut microbiota can result in therapeutic benefit in patients with IBS,” Aroniadis and colleagues wrote. – by Alex Young
Disclosures: Aroniadis reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.
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