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

Laboratorios Ordesa120 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Constipation - Functional

Interventions

Mixture of fibers + PlaceboDIETARY_SUPPLEMENT

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

Placebo + Mixture of fibersDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Boys and girls aged 3 to 12 * Diagnosis of functional constipation according to Rome IV criteria Exclusion Criteria: * Regular use of a dietary fiber supplement, prebiotics or probiotics in the previous 30 days, or who would have been taking bulk-forming agents or laxatives in the 2 weeks prior to the study * Use of medications that cause constipation * Children with organic constipation such as Hirschsprung's disease, cerebral paralysis, anorectal and spinal cord abnormalities and metabolic diseases. * Patients who are not likely to complete follow-up

Locations (3)

Centro de Salud Perpetuo Socorro

Huesca, Aragon, Spain

RECRUITING

Centro de Salud Amparo Poch

Zaragoza, Aragon, Spain

RECRUITING

Centro de Salud Isabel II

Santander, Cantabria, Spain

RECRUITING

Outcomes

Primary Outcomes

Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.

Combined score between this parameters