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

Jinling Hospital, China

Status and phase

Terminated

Phase 2

Conditions

Crohn's Disease

Treatments

Drug: pectin

Study type

Interventional

Funder types

Other

Identifiers

NCT02164877

Pectin-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

17 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged >=17 years with diagnosis of CD for at least 3 months defined by histology or radiology
ileocolonic non-penetrating disease
Moderate active CD with CDAI 250-450
CRP level over normal range
Stable CD therapy with a total steroid dose not exceeding 10mg prednisolone or equivalent for 4 weeks

Exclusion criteria

Infection with enteric pathogen
Usage of probiotics, antibiotics, or prebiotics within the last month
Change in dose of oral steroids or 5-ASA within the last 4 weeks or AZA or MTX in the last 3 months
Dose of steroids exceeds 10 mg prednisolone per day or equivalent
Infusion of IFX or any alternative biological therapy within the last 3 months
Use of rectal 5-ASA or steroids within the last 2 weeks.
Imminent need for surgery or presence of severe disease (CDAI >450)
Pregnancy or lactation
Short bowel syndrome or subtotal/total colectomy
Pure anal disease and previous proctocolectomy
Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator
History of cancer with a disease-free state of less than two years
Patients with penetrating disease or small bowel lesion only.