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

Phase 2TerminatedNCT02164877

Jinling Hospital, China3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Disease

Interventions

pectinDRUG

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

Eligibility

Sex: ALLMin age: 17 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

bacteria translocation in MLN, mesenteric fat and peripheral blood

Bacterial translocation to mesenteric lymph nodes (MLN),mesenteric fat and peripheral blood during laparotomy before surgical mobilization, as determined by DGGE.

Time frame: 4 weeks after treatment

Secondary Outcomes

change of fecal bacteriology

fecal microbiology before and 4 weeks after pectin treatment, as determined by DGGE

Time frame: baseline, week 4

change of fecal SCFA

fecal short chain fatty acid (SCFA) levels before and 4 weeks after treatment, as determined by HPLC.

Time frame: baseline, week 4

clinical response

the percentage of patients achieving a clinical response (fall in CDAI of \>=70 points) at week 4.

Time frame: up to 4 weeks after treatment

change of mucosal Treg numbers

mucosal Treg（FoxP3+CD4+）cell number before and after treatment,as determined by immunofluorescence

Time frame: baseline, week 4

adverse events

gastrointestinal symptoms(borborygmi,flatulence,abdominal pain,diarrhea etc)

Time frame: up to 4 weeks after treatment

Data from ClinicalTrials.gov

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