Status:
UNKNOWN
Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
Lead Sponsor:
Laboratorios Ordesa
Conditions:
Constipation - Functional
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
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 p...
Detailed 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 s...
Eligibility Criteria
Inclusion
- Boys and girls aged 3 to 12
- Diagnosis of functional constipation according to Rome IV criteria
Exclusion
- 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
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04028258
Start Date
February 13 2018
End Date
December 1 2020
Last Update
March 9 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro de Salud Perpetuo Socorro
Huesca, Aragon, Spain, 22006
2
Centro de Salud Amparo Poch
Zaragoza, Aragon, Spain, 50018
3
Centro de Salud Isabel II
Santander, Cantabria, Spain, 39002