NCT04305535

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

March 5, 2020

Last Update Submit

March 11, 2020

Conditions

Crohn DiseaseAbsorption; Disorder, ProteinAbsorption; DisorderAbsorption; Disorder, FatAbsorption; Disorder, CarbohydrateMalnutrition

Keywords

Oligomeric dietPeptidic dietProbioticsOral Nutritional Supplements

Outcome Measures

Primary Outcomes (1)

  • Malabsorption

    Body Weight Change (kg)

    6 months

Secondary Outcomes (2)

  • Changes in the consistency of the stools according to Bristol scale.

    6 months

  • Fat malabsorption

    6 months

Study Arms (3)

Peptidic+Probiotic

ACTIVE COMPARATOR

Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and mix of probiotics during 6 months

Dietary Supplement: Peptidic+Probiotic

Peptidic+Placebo

ACTIVE COMPARATOR

Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months

Dietary Supplement: Peptidic+Placebo

Polymeric+Placebo

PLACEBO COMPARATOR

Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months

Dietary Supplement: Polymeric+Placebo

Interventions

Peptidic+ProbioticDIETARY_SUPPLEMENT

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

Peptidic+Probiotic
Peptidic+PlaceboDIETARY_SUPPLEMENT

Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo

Peptidic+Placebo
Polymeric+PlaceboDIETARY_SUPPLEMENT

Polymeric oral nutritional supplement and a placebo

Polymeric+Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unintentional weight loss of 5% in 6 months or a BMI less than 20kg/m2 or does not get the energy requirements with normal food.
  • Willing to comply with the prescribed diet follow-up for CD.

You may not qualify if:

  • Having received antibiotics in the previous 3 months
  • Having undergone intestinal resection surgery≥70-75%
  • Refuse to participate in the study
  • Comorbidity that allows to suspect survival \<1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Aganzo Yeves

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Crohn DiseasePlatelet Glycoprotein IV DeficiencyMalnutrition

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Miguel Aganzo-Yeves, RD

    Hospital Universitario Fundación Jiménez Díaz

    PRINCIPAL INVESTIGATOR

  • Clotilde Vázquez-Martínez, MD

    Hospital Universitario Fundación Jiménez Díaz

    STUDY DIRECTOR

Central Study Contacts

Miguel A Aganzo-Yeves, RD

CONTACT

+34661774925miguel.aganzo@fjd.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 12, 2020

Study Start

February 13, 2020

Primary Completion

February 1, 2021

Study Completion

June 1, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

ES(1)