Colitis, Ulcerative Clinical Trial
Official title:
Development of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota.
NCT number | NCT03444311 |
Other study ID # | RETOS |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 8, 2018 |
Est. completion date | July 2, 2020 |
Verified date | July 2020 |
Source | AB Biotics, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 tract. It is suspected that an alteration in primary intestinal microbial colonization (dysbiosis) could trigger, or at least contribute to, said oversized immune response. The hypothesis is that the administration of a series of fibers, could improve the bacterial diversity and repair the dysbiosis that has been seen in patients affected by ulcerative colitis, improving the clinical evolution of it. The primary objective of the present study is to know the impact on the microbiota of patients with UC in remission derived from the administration of dietary fibers. The RETOS 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 of fibers, in addition to the tolerability and acceptance by the patient. The clinical applicability derived from this intervention would be to improve the diversity of intestinal flora of patients with ulcerative colitis.
Status | Terminated |
Enrollment | 12 |
Est. completion date | July 2, 2020 |
Est. primary completion date | July 2, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Adult patients (from 18 to 65 years old) diagnosed with ulcerative colitis (not distal), of at least 1 year of evolution of the disease. 2. Patient in clinical remission two months prior to inclusion (Simple Colitis Clinical Activity Index (SCCAI) <4) and fecal calprotectin <150 µg / g. 3. 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Vall d'Hebron | Barcelona |
Lead Sponsor | Collaborator |
---|---|
AB Biotics, SA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To know the impact on the microbiota diversity by 16S rRNA analysis of patients with UC in remission derived from the administration of a new product based on dietary fibers | The phyla and genera relative abundance analysed by 16S rRNA before and after treatment with the two levels of fiber | 12 weeks | |
Secondary | To study the tolerability of the product through questionnaires | Change from baseline in tolerability scores using the DHRS scale (0 no pain-5 severe pain) every 15 days | 4 months | |
Secondary | To study the satisfaction of the product through questionnaires | Change from baseline in satisfaction scores using a (0 do not like-10 like a lot)scale every 15 days | 4 months |
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