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

NCT ID: NCT02164877

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-06-30

Brief 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

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pectin

Patients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks.

Group Type: EXPERIMENTAL

pectin

Intervention Type: DRUG

Patients allocated to experiment group will receive 15g pectin each day

control

Patients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks

Group Type: PLACEBO_COMPARATOR

pectin

Intervention Type: DRUG

Patients allocated to experiment group will receive 15g pectin each day

Interventions

pectin

Patients allocated to experiment group will receive 15g pectin each day

Intervention Type: DRUG

Other Intervention Names

soluble dietary fiber

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Gong

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianfeng Gong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of general surgery,Jinling hospital

Locations

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

Pectin-2014

Identifier Type: -

Identifier Source: org_study_id