Crohn's DiseasePhase 2NCT02164877
Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease
A Phase 2 study testing pectin in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- pectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
About this study
Official title: A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- pectin
- Keywords
- Dietary fiber
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pectinDrug
Also called soluble dietary fiber
Patients allocated to experiment group will receive 15g pectin each day
| Study group | Role | What they receive |
|---|---|---|
| pectin | Experimental | Patients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks. Receives: Drug: pectin |
| control | Placebo comparator | Patients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks Receives: Drug: pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after treatment
Secondary outcomes (5)
change of fecal bacteriology
fecal microbiology before and 4 weeks after pectin treatment, as determined by DGGE
Measured: baseline, week 4
change of fecal SCFA
fecal short chain fatty acid (SCFA) levels before and 4 weeks after treatment, as determined by HPLC.
Measured: baseline, week 4
clinical response
the percentage of patients achieving a clinical response (fall in CDAI of >=70 points) at week 4.
Measured: 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
Measured: baseline, week 4
adverse events
gastrointestinal symptoms(borborygmi,flatulence,abdominal pain,diarrhea etc)
Measured: up to 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2017
- Study completionJun 2017
Why it stopped: Not enough participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Jianfeng Gong, MD, Principal investigator, Department of general surgery,Jinling hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164877
- Sponsor's protocol ID
- Pectin-2014
- Status last verified
- Apr 2018
- First submitted
- 13 Jun 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02164877
- Acronym / sponsor ID
- Pectin-2014
- Conditions
- Crohn's Disease
- Keywords
- Dietary fiber
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants enrolled
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pectin | Experimental | Drug: pectinPatients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks. |
| control | Placebo comparator | Drug: pectinPatients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pectinAlso: soluble dietary fiberPatients allocated to experiment group will receive 15g pectin each day | Drug | control, pectin |
Primary outcome
bacteria translocation in MLN, mesenteric fat and peripheral blood
Time frame: 4 weeks after treatment
Bacterial translocation to mesenteric lymph nodes (MLN),mesenteric fat and peripheral blood during laparotomy before surgical mobilization, as determined by DGGE.
5 secondary outcomes
change of fecal bacteriology
Time frame: baseline, week 4
change of fecal SCFA
Time frame: baseline, week 4
clinical response
Time frame: up to 4 weeks after treatment
change of mucosal Treg numbers
Time frame: baseline, week 4
adverse events
Time frame: up to 4 weeks after treatment
Results and safety
The study was stopped early (reason given: Not enough participants enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfeng Gong, MD principal investigator
Department of general surgery,Jinling hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pectin in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough participants enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacteria translocation in MLN, mesenteric fat and peripheral blood (time frame: 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.