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 bacteriologychange 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
|