Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pectin
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Dietary fiber
Eligibility 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.
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
pectin
control
Arm Description
Patients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks.
Patients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change of fecal bacteriology
fecal microbiology before and 4 weeks after pectin treatment, as determined by DGGE
change of fecal SCFA
fecal short chain fatty acid (SCFA) levels before and 4 weeks after treatment, as determined by HPLC.
clinical response
the percentage of patients achieving a clinical response (fall in CDAI of >=70 points) at week 4.
change of mucosal Treg numbers
mucosal Treg(FoxP3+CD4+)cell number before and after treatment,as determined by immunofluorescence
adverse events
gastrointestinal symptoms(borborygmi,flatulence,abdominal pain,diarrhea etc)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02164877
Brief Title
Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease
Official Title
A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants enrolled
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Dietary fiber
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pectin
Arm Type
Experimental
Arm Description
Patients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Patients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks
Intervention Type
Drug
Intervention Name(s)
pectin
Other Intervention Name(s)
soluble dietary fiber
Intervention Description
Patients allocated to experiment group will receive 15g pectin each day
Primary Outcome Measure Information:
Title
bacteria translocation in MLN, mesenteric fat and peripheral blood
Description
Bacterial translocation to mesenteric lymph nodes (MLN),mesenteric fat and peripheral blood during laparotomy before surgical mobilization, as determined by DGGE.
Time Frame
4 weeks after treatment
Secondary Outcome Measure Information:
Title
change of fecal bacteriology
Description
fecal microbiology before and 4 weeks after pectin treatment, as determined by DGGE
Time Frame
baseline, week 4
Title
change of fecal SCFA
Description
fecal short chain fatty acid (SCFA) levels before and 4 weeks after treatment, as determined by HPLC.
Time Frame
baseline, week 4
Title
clinical response
Description
the percentage of patients achieving a clinical response (fall in CDAI of >=70 points) at week 4.
Time Frame
up to 4 weeks after treatment
Title
change of mucosal Treg numbers
Description
mucosal Treg(FoxP3+CD4+)cell number before and after treatment,as determined by immunofluorescence
Time Frame
baseline, week 4
Title
adverse events
Description
gastrointestinal symptoms(borborygmi,flatulence,abdominal pain,diarrhea etc)
Time Frame
up to 4 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Gong, MD
Organizational Affiliation
Department of general surgery,Jinling hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease
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