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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Constipation - Functional
- Sponsor
- Laboratorios Ordesa
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.
- Last Updated
- 6 years ago
Overview
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 product
- Group B: control product+wash out+study product
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 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
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.
Time Frame: From baseline to 8 weeks
Combined score between this parameters
Secondary Outcomes
- Consistency of stool according to Bristol Stool Form Scale(From baseline to 8 weeks)
- Frequency of stool(From baseline to 8 weeks)
- Change in stool weight(From baseline to 8 weeks)
- Patient anthropometric measures: waist perimeter(Up to 8 weeks)
- Gastrointestinal symptoms related to the constipation(From baseline to 8 weeks)
- Patient anthropometric measures: size(Up to 8 weeks)
- Patient anthropometric measures: weight(Up to 8 weeks)
- Adherence record to the complement intake (Moriski Green test)(At 8 weeks)