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Frozen inoculum from unrelated donors effective for fecal transplant
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Frozen inoculum from unrelated donors is effective for fecal transplants in patients with relapsing Clostridium difficile, according to researchers from Massachusetts General Hospital.
“Of particular importance is the fact that delivery of the inoculum through the upper gastrointestinal tract seems to be comparable to that of colonoscopic delivery, thus eliminating the need for sedation, anesthetic risks and colonic ‘cleanout,’” the researchers wrote in Clinical Infectious Diseases.
In this feasibility study, the researchers compared the efficacy of fecal transplant with frozen inoculum delivered by colonoscopic delivery and by nasogastric tube. Twenty patients, 10 in each treatment arm, were included in the open-label, randomized controlled trial. The patients were aged 7 to 90 years and had refractory or recurrent C. difficile infection.
Unrelated donors were healthy, nonpregnant adults aged 18 to 50 years, with a normal BMI, and not receiving any medications. The donors were screened using the American Association of Blood Banks donor questionnaire and underwent a physical examination and general laboratory testing. Donor feces were screened for enteric pathogens and the donors underwent blood screening for hepatitis A, B and C and HIV. Five donors met the required criteria and each provided three stool samples.
Fourteen of the patients were cured after the first infusion, eight in the colonoscopy arm and six in the nasogastric tube arm. Five patients received a second infusion of feces from the same donor, and all requested administration by nasogastric tube. Four of these patients were cured. The overall cure rate was 90%, and no patient relapsed in the 8-week follow-up period. The median number of bowel movements went from six to one per day in the colonoscopy arm and from seven to two per day in the nasogastric tube arm, 8 weeks after the infusion. There were no serious or unexpected adverse events.
“Recruitment and screening of donors is a lengthy process associated with significant costs, thus preventing the use of [fecal microbiota transplant] in acute situations,” the researchers wrote. “Establishing a repository of prescreened frozen donor stools could make this treatment available for a wider population.”
Disclosure: One researcher is on the board of directors for OpenBiome and another has received a research award from Seres Health.
Perspective
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Colleen Kraft, MD
The paper by Dr. Hohmann’s group has laid the foundation for answering questions on efficacy of fecal microbiota transplant by different routes (colonoscopy and nasogastric), as well as adding to the literature more information in regards to the use of a frozen inoculum. The ability for institutions to use a frozen “stool bank” will allow for more patients to be treated. One of the main goals of the fecal microbiota transplant field is the standardization of the process and this study will become a key part of the description of these procedures.
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