NCT04028258

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

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Laboratorios Ordesa · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Constipation - Functional

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-02-13
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-07-22
• Last updated: 2020-03-09

Locations

3 sites across 1 country: Spain