Crohn's Disease Clinical Trial
Official title:
A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease
Verified date | April 2018 |
Source | Jinling Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | June 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | change of fecal bacteriology | fecal microbiology before and 4 weeks after pectin treatment, as determined by DGGE | baseline, week 4 | |
Secondary | change of fecal SCFA | fecal short chain fatty acid (SCFA) levels before and 4 weeks after treatment, as determined by HPLC. | baseline, week 4 | |
Secondary | 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 | |
Secondary | change of mucosal Treg numbers | mucosal Treg(FoxP3+CD4+)cell number before and after treatment,as determined by immunofluorescence | baseline, week 4 | |
Secondary | adverse events | gastrointestinal symptoms(borborygmi,flatulence,abdominal pain,diarrhea etc) | up to 4 weeks after treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03815851 -
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
|
N/A | |
Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
Completed |
NCT02883452 -
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
|
Phase 1 | |
Recruiting |
NCT04777656 -
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
|
Phase 3 | |
Terminated |
NCT03017014 -
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
|
||
Recruiting |
NCT06053424 -
Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
|
Phase 1 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
Terminated |
NCT02882841 -
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
|
N/A | |
Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
Completed |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
Terminated |
NCT02417974 -
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
|
Phase 2 | |
Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
Completed |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
Completed |
NCT01951326 -
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
|
Phase 3 |