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

Primary Purpose

Crohn Disease, Absorption; Disorder, Protein, Absorption; Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Peptidic+Probiotic

Peptidic+Placebo

Polymeric+Placebo

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Oligomeric diet, Peptidic diet, Probiotics, Oral Nutritional Supplements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Miguel Aganzo YevesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Peptidic+Probiotic

Peptidic+Placebo

Polymeric+Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Malabsorption

Body Weight Change (kg)

Secondary Outcome Measures

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

Bristol scale: type 1= separate hard lumps, type 2= sausage shaped but lumpy, type 3= like a sausage but with cracks on ots surface, type 4= like a sausage or sanake, smooth and soft, type 5= soft blobs with clear cut-edges, type 6= fluffy pieces with ragged edges, a mushy stool, type 7 = watery, no solid pieces.

Fat malabsorption

Presence of fat in the stool

Full Information

NCT ID

NCT04305535

First Posted

March 5, 2020

Last Updated

March 11, 2020

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborators

Adventia Pharma, Biopolis S.L.

1. Study Identification

Unique Protocol Identification Number

NCT04305535

Brief Title

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

Official Title

Clinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 13, 2020 (Actual)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborators

Adventia Pharma, Biopolis S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Oligomeric diet, Peptidic diet, Probiotics, Oral Nutritional Supplements

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peptidic+Probiotic

Arm Type

Active Comparator

Arm Description

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

Arm Title

Peptidic+Placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Polymeric+Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Peptidic+Probiotic

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Peptidic+Placebo

Intervention Description

Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Polymeric+Placebo

Intervention Description

Polymeric oral nutritional supplement and a placebo

Primary Outcome Measure Information:

Title

Malabsorption

Description

Body Weight Change (kg)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

Title

Fat malabsorption

Description

Presence of fat in the stool

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miguel A Aganzo-Yeves, RD

Phone

+34661774925

miguel.aganzo@fjd.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miguel Aganzo-Yeves, RD

Organizational Affiliation

Hospital Universitario Fundación Jiménez Díaz

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Clotilde Vázquez-Martínez, MD

Organizational Affiliation

Hospital Universitario Fundación Jiménez Díaz

Official's Role

Study Director

Facility Information:

Facility Name

Miguel Aganzo Yeves

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miguel A Aganzo-Yeves, RD

Phone

+34661774925

miguel.aganzo@fjd.es

12. IPD Sharing Statement

Learn more about this trial

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

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