Clinical Trials Directory

Trials / Terminated

TerminatedNCT02164877

Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease

A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Jinling Hospital, China · Academic / Other
Sex
All
Age
17 Years – 40 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the effect of soluble dietary fiber on bacterial translocation and mucosal immunology in patients with Crohn's disease.

Detailed description

Bacterial translocation (BT) is a proposed mechanism of CD. Microorganisms can be cultured from 18-48% of draining mesenteric lymph nodes from CD patients. A breakdown in barrier function in "late stage" CD has been observed in patients requiring surgery. In addition, it was found that BT influences the response to biological therapy and clinical relapse in CD. Therefore, reducing BT may be of therapeutic importance in treatment for CD. The role of soluble dietary fiber in Crohn's disease (CD) is still inconclusive. Population based studies have shown that long-term intake of dietary fiber is associated with lower risk of CD. However, meta-analysis did not show benefit in inducing or maintaining remission. In addition, the possible mechanism of dietary fiber on CD is still unclear. The rationale relates to the beneficial effects of fiber may be due to the production of the fiber metabolites short-chain fatty acids (SCFAs), particularly butyrate. Dietary substrates may modify the commensal microbiota or their metabolites or enhance epithelial barrier function. Recently, it was found that dietary fiber metabolites SCFA is regulatory of mucosal regulatory T cells. The current study is to examine the impact of dietary fiber on bacterial translocation,intestinal luminal microbiology, and mucosal immunology in CD patients.

Conditions

Interventions

TypeNameDescription
DRUGpectinPatients allocated to experiment group will receive 15g pectin each day

Timeline

Start date
2014-06-01
Primary completion
2017-05-01
Completion
2017-06-01
First posted
2014-06-17
Last updated
2018-04-17

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02164877. Inclusion in this directory is not an endorsement.