Combined Nutritional Therapies for the Treatment of Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03444311
• Date of registration: 08/02/2018
• Prospective Registration: Yes
• Primary sponsor: AB Biotics, SA
• Public title: Combined Nutritional Therapies for the Treatment of Ulcerative Colitis
• Scientific title: Development of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota.
• Date of first enrolment: March 8, 2018
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03444311
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Ariana Salavert, PhD
• Affiliation: Ab-biotics

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Dietary Supplement: A: 1 dosis

Dietary Supplement: B: 2 dosis

Primary Outcome(s)

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 [Time Frame: 12 weeks]

Secondary Outcome(s)

To study the satisfaction of the product through questionnaires [Time Frame: 4 months]

To study the tolerability of the product through questionnaires [Time Frame: 4 months]

Secondary ID(s)

RETOS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors