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

• Status: Terminated
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Treatments: Pectin

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.