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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-13

Study Completion Date

2020-12-31

Brief Summary

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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

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Detailed Description

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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

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Constipation - Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A: study+wash out+control

Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks)

Group Type OTHER

Mixture of fibers + Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Group B: control+wash out+study

Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks)

Group Type OTHER

Placebo + Mixture of fibers

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No