Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation (VEGY-DOWN(A))

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

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

Study Overview

• Status: Unknown
• Conditions: Constipation - Functional
• Intervention / Treatment: Dietary supplement: Mixture of fibers + Placebo; Dietary supplement: Placebo + Mixture of fibers

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Aragon
    • Huesca, Aragon, Spain, 22006
      • Recruiting
      • Centro de Salud Perpetuo Socorro
      • Contact: Jorge Fuertes, MD; Phone Number: 974 225 450
  • Aragón
    • Zaragoza, Aragón, Spain, 50018
      • Recruiting
      • Centro de Salud Amparo Poch
      • Contact: Isabel Lostal, MD; Phone Number: 976 547 499
  • Cantabria
    • Santander, Cantabria, Spain, 39002
      • Recruiting
      • Centro de Salud Isabel II
      • Contact: Maria Rosa Pardo; Phone Number: 942218161

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A: study+wash out+control; Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks)	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)
Other: Group B: control+wash out+study; Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks)	Dietary supplement: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Investigators: Principal Investigator: Gerardo Rodríguez, MD, Instituto de Investigación Sanitaria Aragón

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Constipation; Fiber
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: VEGY-DOWN (A)-05-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No