NCT02526849

Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation

A Randomized Controlled Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.

Detailed description

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.

Conditions

• Slow Transit Constipation

Interventions

Type	Name	Description
DRUG	Fecal microbiota transplantation (FMT)	Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
BEHAVIORAL	Conventional treatment	Conventional treatment was taken by both of two groups. If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax®, Ipsen, Paris, France). If ineffective, an enema could be used.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2015-08-18
• Last updated: 2016-11-04

Locations

1 site across 1 country: China