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Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease

NCT04305535 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2020-03-12

No results posted yet for this study

Summary

This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.

Conditions

  • Crohn Disease
  • Absorption; Disorder, Protein
  • Absorption; Disorder
  • Absorption; Disorder, Fat
  • Absorption; Disorder, Carbohydrate
  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Peptidic+Probiotic

Oligomeric oral nutritional supplement (Bi1 peptidic) and a mix of probiotics * Bifidobacterium animalis subsp. lactis BPL1, * Lactobacillus rhamnosus BPL15, * Lactobacillus rhamnosus CNCM i-4036 * Bifidobacterium longum ES1

DIETARY_SUPPLEMENT

Peptidic+Placebo

Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo

DIETARY_SUPPLEMENT

Polymeric+Placebo

Polymeric oral nutritional supplement and a placebo

Sponsors & Collaborators

  • Adventia Pharma

    collaborator INDUSTRY

  • Biopolis S.L.

    collaborator INDUSTRY

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Miguel Aganzo-Yeves, RD · Hospital Universitario Fundación Jiménez Díaz

  • Clotilde Vázquez-Martínez, MD · Hospital Universitario Fundación Jiménez Díaz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2021-02-28
Completion
2021-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305535 on ClinicalTrials.gov