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

L

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

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

Trial contacts and locations

3

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Central trial contact

Roser De Castellar, MD

Data sourced from clinicaltrials.gov

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