|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT04006886 |
|
Date of registration:
|
02/07/2019 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)
PSt-GFD |
|
Scientific title:
|
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study |
|
Date of first enrolment:
|
July 11, 2017 |
|
Target sample size:
|
17 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT04006886 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- diagnosed PSC-associated colitis without relevant clinical activity after last
coloscopy.
Exclusion Criteria:
- patients with coeliac disease or wheat allergy
- patients with active colitis
- patients already on gluten-free diet
- liver transplanted patients
- patients also diagnosed with autoimmune hepatites (PSC-AIH overlap)
- coloscopy within 2 months before study
- Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study
- antibiotics within 3 month before study
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Reduction of Intestinal Inflammatory Activity
|
|
Intervention(s)
|
|
Dietary Supplement: Gluten-free diet
|
|
Primary Outcome(s)
|
|
Reduction of intestinal inflammatory activity
[Time Frame: 2 months]
|
|
Secondary Outcome(s)
|
|
Reduction of inflammatory cells/markers in the blood
[Time Frame: 2 months]
|
|
Change of symptoms with change of diet.
[Time Frame: 2 months]
|
|
Inflammatory activity of the liver
[Time Frame: 2 months]
|
|
Quality of life
[Time Frame: 2 months]
|
|
Changes in patients microbiota
[Time Frame: 2 months (5 months with follow-up)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|