Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
- Conditions
- Constipation - Functional
- Interventions
- Dietary Supplement: Placebo + Mixture of fibersDietary Supplement: Mixture of fibers + Placebo
- Registration Number
- NCT04028258
- Lead Sponsor
- Laboratorios Ordesa
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Boys and girls aged 3 to 12
- Diagnosis of functional constipation according to Rome IV 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group B: control+wash out+study Placebo + Mixture of fibers Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks) Group A: study+wash out+control Mixture of fibers + Placebo Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks)
- Primary Outcome Measures
Name Time Method 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. From baseline to 8 weeks Combined score between this parameters
- Secondary Outcome Measures
Name Time Method Consistency of stool according to Bristol Stool Form Scale From baseline to 8 weeks Valuation of stool characteristics (Bristol scale): 7 types of consistency, where type 1 is the hardest consistency.
Frequency of stool From baseline to 8 weeks Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week
Change in stool weight From baseline to 8 weeks Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15%
Patient anthropometric measures: waist perimeter Up to 8 weeks Waist perimeter (cm)
Gastrointestinal symptoms related to the constipation From baseline to 8 weeks Record in the patient's dairy all the gastrointestinal symptoms during the study
Patient anthropometric measures: size Up to 8 weeks Anthropometric records: size (cm)
Patient anthropometric measures: weight Up to 8 weeks Anthropometric records: weight (Kg)
Adherence record to the complement intake (Moriski Green test) At 8 weeks 4 questions to the patient about treatment adherence.Patients who follow treatment are considered to be those who answer NO to the four questions and not to those who answer YES to one or more.
Trial Locations
- Locations (3)
Centro de Salud Isabel II
🇪🇸Santander, Cantabria, Spain
Centro de Salud Perpetuo Socorro
🇪🇸Huesca, Aragon, Spain
Centro de Salud Amparo Poch
🇪🇸Zaragoza, Aragón, Spain