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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pectin | Experimental | Patients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks. |
|
| control | Placebo Comparator | Patients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pectin | Drug | Patients allocated to experiment group will receive 15g pectin each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change of fecal bacteriology | fecal microbiology before and 4 weeks after pectin treatment, as determined by DGGE | baseline, week 4 |
| change of fecal SCFA | fecal short chain fatty acid (SCFA) levels before and 4 weeks after treatment, as determined by HPLC. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianfeng Gong, MD | Department of general surgery,Jinling hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010368 | Pectins |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
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| baseline, week 4 |
| clinical response | the percentage of patients achieving a clinical response (fall in CDAI of >=70 points) at week 4. | up to 4 weeks after treatment |
| change of mucosal Treg numbers | mucosal Treg(FoxP3+CD4+)cell number before and after treatment,as determined by immunofluorescence | baseline, week 4 |
| adverse events | gastrointestinal symptoms(borborygmi,flatulence,abdominal pain,diarrhea etc) | up to 4 weeks after treatment |
| D007410 | Intestinal Diseases |
| D002241 |
| Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |