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NCT03444311

Combined Nutritional Therapies for the Treatment of Ulcerative Colitis

Terminated NA Last updated 8 July 2020
What this trial tests

NA trial testing A: 1 dosis in Colitis, Ulcerative in 12 participants. Terminated before completion.

Timeline
8 March 2018
Primary endpoint
2 July 2019
2 July 2020

Quick facts

Lead sponsorAB Biotics, SA
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment12
Start date8 March 2018
Primary completion2 July 2019
Estimated completion2 July 2020
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

AB Biotics, SA — full company profile →

Who can join

Adults 18 to 65, any sex, with Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application.
    Murphy EJ, Rezoagli E, Major I, Rowan NJ, et al · · 2020 · cited 121× · PMID 33322069 · DOI 10.3390/jof6040356

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Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

Other AB Biotics, SA trials

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Data sources for this page

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