Trial | NCT04028258  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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 Started
Feb 13
2018
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
Mar 09
2020

Dietary Supplement Mixture of fibers + Placebo [maltodextrin, prunus domestica]

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)

Group A: study+wash out+control Other

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

Group B: control+wash out+study Other

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

Criteria 

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
No Results Posted