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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02164877
• Date of registration: 13/06/2014
• Prospective Registration: No
• Primary sponsor: Jinling Hospital, China
• Public title: Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease
• Scientific title: A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease
• Date of first enrolment: June 2014
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02164877
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Jianfeng Gong, MD
• Affiliation: Department of general surgery,Jinling hospital

Key inclusion & exclusion 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.



Age minimum: 17 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: pectin

Primary Outcome(s)

bacteria translocation in MLN, mesenteric fat and peripheral blood [Time Frame: 4 weeks after treatment]

Secondary Outcome(s)

adverse events [Time Frame: up to 4 weeks after treatment]

change of fecal bacteriology [Time Frame: baseline, week 4]

change of mucosal Treg numbers [Time Frame: baseline, week 4]

change of fecal SCFA [Time Frame: baseline, week 4]

clinical response [Time Frame: up to 4 weeks after treatment]

Secondary ID(s)

Pectin-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors