Slow Transit Constipation Clinical Trial
Official title:
A Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
The purpose of this study is to evaluate the effect of fecal microbiota transplantation 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 our 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, we suppose that reshaping the
gut microbiome with FMT would be effective for patients with slow transit constipation.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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