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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02164877
• Other study ID #: Pectin-2014
• Status: Terminated
• Phase: Phase 2
• First received: June 13, 2014
• Last updated: April 14, 2018
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: April 2018
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks after treatment
Secondary	change of fecal bacteriology	fecal microbiology before and 4 weeks after pectin treatment, as determined by DGGE	baseline, week 4
Secondary	change of fecal SCFA	fecal short chain fatty acid (SCFA) levels before and 4 weeks after treatment, as determined by HPLC.	baseline, week 4
Secondary	clinical response	the percentage of patients achieving a clinical response (fall in CDAI of >=70 points) at week 4.	up to 4 weeks after treatment
Secondary	change of mucosal Treg numbers	mucosal Treg(FoxP3+CD4+)cell number before and after treatment,as determined by immunofluorescence	baseline, week 4
Secondary	adverse events	gastrointestinal symptoms(borborygmi,flatulence,abdominal pain,diarrhea etc)	up to 4 weeks after treatment