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

Constipation - Functional Clinical Trial

— VEGY-DOWN(A)  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028258
• Other study ID #: VEGY-DOWN (A)-05-17
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Laboratorios Ordesa
• Contact: Roser De Castellar, MD
• Phone: +34 902105243
• Email: Roser.DeCastellar[@]ordesa.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Dietary Supplement:
• Mixture of fibers + Placebo
Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)
• Placebo + Mixture of fibers
Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)

Locations

Country	Name	City	State
Spain	Centro de Salud Perpetuo Socorro	Huesca	Aragon
Spain	Centro de Salud Isabel II	Santander	Cantabria
Spain	Centro de Salud Amparo Poch	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Ordesa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in stool weight	Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15%	From baseline to 8 weeks
Secondary	Gastrointestinal symptoms related to the constipation	Record in the patient's dairy all the gastrointestinal symptoms during the study	From baseline to 8 weeks
Secondary	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
Secondary	Patient anthropometric measures: weight	Anthropometric records: weight (Kg)	Up to 8 weeks
Secondary	Patient anthropometric measures: size	Anthropometric records: size (cm)	Up to 8 weeks
Secondary	Patient anthropometric measures: waist perimeter	Waist perimeter (cm)	Up to 8 weeks