Clinical trial NCT04028258: Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation - Functional
Keywords: Constipation
Fiber
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
First posted: 2019-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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.
timeFrame: From baseline to 8 weeks
Secondary outcomes:
measure: Consistency of stool according to Bristol Stool Form Scale
timeFrame: From baseline to 8 weeks
measure: Frequency of stool
timeFrame: From baseline to 8 weeks
measure: Change in stool weight
timeFrame: From baseline to 8 weeks
measure: Gastrointestinal symptoms related to the constipation
timeFrame: From baseline to 8 weeks
measure: Adherence record to the complement intake (Moriski Green test)
timeFrame: At 8 weeks
measure: Patient anthropometric measures: weight
timeFrame: Up to 8 weeks
measure: Patient anthropometric measures: size
timeFrame: Up to 8 weeks
measure: Patient anthropometric measures: waist perimeter
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Huesca
country: Spain
facility: Centro de Salud Perpetuo Socorro
state: Aragon
city: Zaragoza
country: Spain
facility: Centro de Salud Amparo Poch
state: Aragón
city: Santander
country: Spain
facility: Centro de Salud Isabel II
state: Cantabria
Study officials:
affiliation: Instituto de Investigación Sanitaria Aragón
name: Gerardo Rodríguez, MD
role: PRINCIPAL_INVESTIGATOR
References: