Study Questions Fecal Transplant for Gut Infection
Another may be the large volume of stool given in this study.
“I cannot imagine any patient would be able to retain that volume of stool for any length of time,” Kelly said.
The study differs from others because the Canadian team was careful to include only patients with documented C. difficile recurrence, “and this is a strength of this study,” Kelly noted.
Hota and her colleagues said there’s an urgent need for more rigorous research exploring, for example, the optimal dose and delivery, donor selection and timing of treatment.
Their study treated 30 patients with recurrent C. difficile — 14 got standard treatment and 16 got fecal transplant. However, two dropouts left only 12 in the standard treatment group. Unlike blinded studies, patients and researchers knew which treatment was being administered.
Patients in the fecal transplant group were given a 14-day course of oral vancomycin followed by a single fecal enema. The antibiotic was given to ensure patients’ diarrhea was under control before introducing donor stool, Hota said.
The standard treatment group received a 14-day course of oral vancomycin, followed by four weeks of tapering doses of the antibiotic.
Patients were followed for 120 days, since many recurrences of C. difficile occur within three months, Hota explained.
After an interim analysis, researchers stopped the trial because the results showed no real difference in outcomes.
Just over half of the fecal transplant patients and more than 40 percent of the patients on standard treatment experienced a recurrence. In other words, the infection cleared up in about 44 percent of fecal transplant patients and 58 percent of patients on standard care.
“It actually looks like there’s really no absolute risk reduction with fecal transplant compared to oral vancomycin,” Hota said.
However, fecal transplant has the added benefit of getting patients off antibiotics in a disease driven by antibiotic exposure, she said.
The message is not that fecal transplants are not effective, Hota added. “We need to learn more about doing this properly,” and this study contributes to that knowledge, she said.
The findings were published recently in the journal Clinical Infectious Diseases.
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