Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation — VEGY-DOWN(A)  

Constipation - Functional Clinical Trial

Official title: Randomized, Controlled, Crossover, Double-blind Clinical Trial on the Effect of a Mixture of Plant-based Fibers and Carbohydrates on Intestinal Transit in Children Aged 3 to 12 Diagnosed With Functional Constipation

Status Recruiting

Clinical Trial 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

Clinical Trial Description

All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out.

• Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber.

• Control: Placebo supplement: maltodextrin and plum flakes ;

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

• NCT number: NCT04028258
• Study type: Interventional
• Source: Laboratorios Ordesa
• Contact: Roser De Castellar, MD
• Phone: +34 902105243
• Email: Roser.DeCastellar@ordesa.es
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2018
• Completion date: December 2020