DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Jinling Hospital, China
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: pectin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Jinling Hospital, China

Official(s) and/or principal investigator(s):
Jianfeng Gong, MD, Principal Investigator, Affiliation: Department of general surgery,Jinling hospital

Overall contact:
Jianfeng Gong, MD, Phone: +86-25-80860036, Email: gongjianfeng@aliyun.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: bacteria translocation in MLN, mesenteric fat and peripheral blood

Secondary outcome:

change of fecal bacteriology

change of fecal SCFA

clinical response

change of mucosal Treg numbers

adverse events

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.

Eligibility

Minimum age: 17 Years. Maximum age: 40 Years. Gender(s): Both.

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.

Locations and Contacts

Jianfeng Gong, MD, Phone: +86-25-80860036, Email: gongjianfeng@aliyun.com

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University, Nanjing, Jiangsu 210002, China; Recruiting
Ning Li, MD, Phone: +86-25-80860089, Email: liningrigs@vip.sina.com
Additional Information

Starting date: June 2014
Last updated: June 13, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017