Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Constipation - Functional

Intervention / Treatment
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* Dietary Supplement: Mixture of fibers + Placebo
* Dietary Supplement: Placebo + Mixture of fibers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: study+wash out+control<br>Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks) | Dietary Supplement: Mixture of fibers + Placebo<br>* Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)<br>|
| Other: Group B: control+wash out+study<br>Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks) | Dietary Supplement: Placebo + Mixture of fibers<br>* Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Combined score between this parameters | From baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency of stool according to Bristol Stool Form Scale | Valuation of stool characteristics (Bristol scale): 7 types of consistency, where type 1 is the hardest consistency. | From baseline to 8 weeks | 
| Frequency of stool | Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week | From baseline to 8 weeks | 
| Change in stool weight | Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15% | From baseline to 8 weeks | 
| Gastrointestinal symptoms related to the constipation | Record in the patient's dairy all the gastrointestinal symptoms during the study | From baseline to 8 weeks | 
| Adherence record to the complement intake (Moriski Green test) | 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. | At 8 weeks | 
| Patient anthropometric measures: weight | Anthropometric records: weight (Kg) | Up to 8 weeks | 
| Patient anthropometric measures: size | Anthropometric records: size (cm) | Up to 8 weeks | 
| Patient anthropometric measures: waist perimeter | Waist perimeter (cm) | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Fiber