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

Laboratorios Ordesa

Status: Unknown

Conditions: Constipation - Functional

Treatments: Dietary Supplement: Mixture of fibers + Placebo; Dietary Supplement: Placebo + Mixture of fibers

Study type: Interventional

Funder types: Industry

Identifiers

NCT04028258

VEGY-DOWN (A)-05-17

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Group A: study+wash out+control

Other group

Description:

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

Treatment:

Dietary Supplement: Mixture of fibers + Placebo

Group B: control+wash out+study

Other group

Description:

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

Treatment:

Dietary Supplement: Placebo + Mixture of fibers