Combined Nutritional Therapies for the Treatment of Ulcerative Colitis

NCT03444311 | Terminated

• 1 other identifier: RETOS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colitis, Ulcerative

Keywords

microbiota; ulcerative colitis; fiber; probiotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To study the tolerability of the product through questionnaires

  4 months

• To study the satisfaction of the product through questionnaires

  4 months

Study Arms (2)

A: 1 dosis

ACTIVE COMPARATOR

1 dosis (3E+09 cfu/day + 6 g of fiber/day)

Dietary Supplement: A: 1 dosis

B: 2 dosis

ACTIVE COMPARATOR

2 dosis (3E+09 cfu/day + 12 g of fiber/day)

Dietary Supplement: B: 2 dosis

Interventions

A: 1 dosis DIETARY_SUPPLEMENT

1 dosis (3E+09 cfu/d + 6 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups. Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B Composition of an envelope of formula A: Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6 Composition of an envelope of formula B: Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6

A: 1 dosis

B: 2 dosis DIETARY_SUPPLEMENT

1 dosis (3E+09 cfu/d + 12 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups. Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B Composition of an envelope of formula A: Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6 Composition of an envelope of formula B: Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6

B: 2 dosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (from 18 to 65 years old) diagnosed with ulcerative colitis (not distal), of at least 1 year of evolution of the disease.
• 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

You may not qualify if:

• Patients with ulcerative proctitis only
• 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.

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ariana Salavert, PhD

  Ab-biotics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 23, 2018
• Study Start: March 8, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

ES (1)