NCT02164877

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2.9 years

First QC Date

June 13, 2014

Last Update Submit

April 14, 2018

Conditions

Crohn's Disease

Keywords

Dietary fiber

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • change of fecal bacteriology

    baseline, week 4

  • change of fecal SCFA

    baseline, week 4

  • clinical response

    up to 4 weeks after treatment

  • change of mucosal Treg numbers

    baseline, week 4

  • adverse events

    up to 4 weeks after treatment

Study Arms (2)

pectin

EXPERIMENTAL

Patients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks.

Drug: pectin

control

PLACEBO COMPARATOR

Patients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks

Drug: pectin

Interventions

pectinDRUG

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

Also known as: soluble dietary fiber
controlpectin

Eligibility Criteria

Age17 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Pectins

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Jianfeng Gong, MD

    Department of general surgery,Jinling hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

CN(1)