MedTrace Logo

Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation

NCT04028258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-03-09

No results posted yet for this study

Summary

Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence:

* Group A: study product+wash out+control product
* Group B: control product+wash out+study product

Conditions

  • Constipation - Functional

Interventions

DIETARY_SUPPLEMENT

Mixture of fibers + Placebo

Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)

DIETARY_SUPPLEMENT

Placebo + Mixture of fibers

Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)

Sponsors & Collaborators

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Gerardo Rodríguez, MD · Instituto de Investigación Sanitaria Aragón

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

More Related Trials

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 NCT04028258 on ClinicalTrials.gov