Slow Transit Constipation Clinical Trial
Official title:
Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation: a Randomized Controlled Study
The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh FMT in adults with slow transit constipation.
Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide
general population. Constipation frequency appears to augment with increasing age,
particularly after 65 years old.
Recent evidence in the literature and collected in the investigators' laboratory confirm
that constipation can be a consequence of intestinal dysbiosis, with an increase of
potentially pathogenic microorganisms and a decrease of potentially beneficial
microorganisms. These alterations may affect the motility and metabolic environment of
colon, especially the production of short chain fatty acids (SCFAs).
A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal
microbiota transplantation (FMT). There has been growing interest in the use of fecal
microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI)
and other extraintestinal conditions (e.g. IBD). Similarly, the investigators suppose that
reshaping the gut microbiome with FMT would be effective for patients with slow transit
constipation.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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