Status:
TERMINATED
Combined Nutritional Therapies for the Treatment of Ulcerative Colitis
Lead Sponsor:
AB Biotics, SA
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Ulcerative colitis (UC) is an entity of complex etiology where environmental, genetic and intestinal microflora-related factors trigger and perpetuate a chronic inflammation of the gastrointestinal tr...
Detailed Description
The Phase 1 study is a pilot project in which a population of patients with UC is tested for the effect on the composition of the microbiota that would have the administration of various combinations ...
Eligibility Criteria
Inclusion
- Adult patients (from 18 to 65 years old) diagnosed with ulcerative colitis (not distal), of at least 1 year of evolution of the disease.
- Patient in clinical remission two months prior to inclusion (Simple Colitis Clinical Activity Index (SCCAI) \<4) and fecal calprotectin \<150 μg / g.
- At least one outbreak in the last year that required systemic corticosteroids or escalating treatment (initiation of thiopurines, optimization of thiopurines, initiation of anti-TNF-alpha, intensification of anti-TNF-alpha, initiation of vedolizumab). At the time of entry into the study, the patient must carry with stable medication at least 2 months in the case of anti-TNF-alpha and mesalazine and 5 months in the case of thiopurine, and without treatment with corticosteroids
Exclusion
- Patients with ulcerative proctitis only
- Patients who have received antibiotics the month prior to inclusion until completion
- Usual consumption of probiotics excluding fermented milk (yogurt, kefir ...).
- Supplementation with dietary fiber (without taking into account the one administered in the study).
- The smoking habit is allowed, although the beginning or abandonment of it from two months before the end of the study will have to be documented.
- Patients undergoing hypocaloric diets
- Patients with stenosis or intestinal surgery
- Patients with primary sclerosing cholangitis
- Patients under treatment with ursodeoxycholic acid
- Patients under treatment with ion exchange resins
- Patients under treatment with acenocoumarol (Sintrom)
- The taking of proton pump inhibitors (PPIs) is allowed but their consumption must be controlled, not allowing them to start or suspend their intake during the study.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03444311
Start Date
March 8 2018
End Date
July 2 2020
Last Update
July 8 2020
Active Locations (1)
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1
Hospital Vall d'Hebron
Barcelona, Spain, 08035