NCT02291354

Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation

A Randomized, Controlled Study of Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (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 synergism of Soluble Dietary Fiber with Fecal Microbiota Transplantation in Adult Patients with Slow Transit Constipation.

Detailed description

Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Recent evidence in the literature and collected in our laboratory confirm that constipation can be a consequence of intestinal dysbiosis, which may affect the motility and metabolic environment of colon. Fecal Microbiota Transplantation (FMT) is temporarily effective for patients with slow transit constipation. However, the transplanted microflora cannot maintain for a long time. Along with the gut microbiota returning to the original state, the symptoms relapse. Pectin is a kind of soluble dietary fiber, producing short chain fatty acids (SCFAs) after a series of fermentation by gut flora to supply the energy for epithelial cells, regulate intestinal PH, promote intestinal motility and join effort in immune regulation with intestinal lymphoid tissue. Therefore, we conceive that pectin could promote the colonization of probiotics and reduce adhesion of pathogens.

Conditions

• Slow Transit Constipation

Interventions

Type	Name	Description
DRUG	Pectin	Patients allocated to experiment group will receive 12 g pectin each day for 12 weeks.
OTHER	Placebo	Patients allocated to experiment group will receive 12 g maltodextrin each day for 12 weeks.
PROCEDURE	Fecal microbiota transplantation (FMT)	Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-03-01
• Completion: 2016-06-01
• First posted: 2014-11-14
• Last updated: 2016-02-04

Locations

1 site across 1 country: China