Fecal microbiota transplantation studies are poorly reported

Last Updated: 2017-05-23

By Will Boggs MD

NEW YORK (Reuters Health) - Important components of fecal microbiota transplantation (FMT) intervention studies are poorly reported, thereby compromising their replication and interpretation, according to a systematic review.

FMT is a complex intervention with multiple components and several organizational challenges, and it remains unclear precisely which factors affect FMT’s efficacy and safety.

Dr. Aida Bafeta from INSERM U1153, Hopital Hotel-Dieu, Paris, France, and colleagues reviewed 85 published studies of FMT. Specifically, they examined how those studies were conducted and reported, focusing on whether the main methodological components of the FMT intervention were described adequately.

The researchers considered seven key methodological components: donors’ eligibility criteria, delay between collection and transplantation, type of diluents used, type of stool, amount of stools used, number of transplantations performed, and mode of administration. They deemed FMT interventions that reported all seven items to be “adequate” and those lacking one or more items to be “inadequate,” according to the May 23 Annals of Internal Medicine report.

Nearly 90% of the reports failed to give the eligibility criteria for donors, describe the relationship between donor and patient, or report the characteristics of donors, and only 5% provided both the number of donors and the number of donations per donor.

All but two of the 85 reports lacked descriptions of the materials used for collecting stools, the period of collection, or the preparation of donors for collecting stools. Eighty percent of reports did not give the type of stools used for infusion (fresh or frozen), volume of preparation, amount of stool used, or duration of conservation of stools; 60% did not describe the preparation of patients for transplantation, the mode of infusion administration, or the number of infusions per patient.

Only 9% of the studies adequately reported all seven methodological components of the FMT interventions.

“This review reinforces the need to develop international recommendations for standardizing FMT to facilitate reporting and implementation in clinical practice,” the researchers conclude.

Dr. Vincent B. Young of the University of Michigan, Ann Arbor, who wrote an editorial accompanying the study, told Reuters Health by email, “Most surprising (and somewhat concerning) is the fact that most of the published reports testing the use of FMT describe their specific methods in such a way that others would have a difficult (or even impossible) time trying to replicate the results.”

“I think physicians need to realize that the therapeutic manipulation of the microbiota is still in its early stages,” he said. “While evidence is accumulating for the use of FMT in recurrent C. difficile infection (CDI), there is considerable variation in the methods that have been reported for this intervention - the ‘final word’ on how to best use this for CDI is not yet in. Additionally, the use of FMT for other diseases is in even more preliminary, and the use of this therapy needs to be done as part of clinical trials.”

“In my editorial, I did make a point that setting ‘standard’ methods for performing FMT at this time is probably premature,” Dr. Young said. “Instead, I proposed that it would be reasonable to establish registries for FMT trials for specific indications (for example, for recurrent CDI or inflammatory bowel disease). This could include both a methods repository and, perhaps, also a biospecimen repository.”

Dr. Maria Vehreschild from University Hospital of Cologne, Koln, Germany, recently reported on the safety and efficacy of FMT as a treatment for recurrent CDI. She told Reuters Health by email, “The results are not surprising, as FMT remains one of the least harmonized and regulated treatment methods worldwide.”

“In comparison to Europe, regulatory standards in the U.S. have facilitated the conduct of clinical care and clinical trials in the area of FMT,” she said. “It would be very helpful if the EMA (European Medicines Agency) could agree on a similar set of standards.”

Regarding who should establish such standards, Dr. Vehreschild suggested “specialists in the field as representatives of medical societies. The fields involved should, in my opinion, include the following: infectious diseases, gastroenterology, microbiology and virology, and pharmacology. Depending on the indication to be treated, further experts from the medical field covering this indication should be involved.”

Dr. Bafeta did not respond to a request for comments.

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Ann Intern Med 2017.