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

Primary Purpose

Constipation - Functional

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mixture of fibers + Placebo
Placebo + Mixture of fibers
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional focused on measuring Constipation, Fiber

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Salud Perpetuo SocorroRecruiting
  • Centro de Salud Amparo PochRecruiting
  • Centro de Salud Isabel IIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A: study+wash out+control

Group B: control+wash out+study

Arm Description

Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks)

Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Frequency of stool
Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week
Change in stool weight
Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15%
Gastrointestinal symptoms related to the constipation
Record in the patient's dairy all the gastrointestinal symptoms during the study
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.
Patient anthropometric measures: weight
Anthropometric records: weight (Kg)
Patient anthropometric measures: size
Anthropometric records: size (cm)
Patient anthropometric measures: waist perimeter
Waist perimeter (cm)

Full Information

First Posted
July 15, 2019
Last Updated
March 6, 2020
Sponsor
Laboratorios Ordesa
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1. Study Identification

Unique Protocol Identification Number
NCT04028258
Brief Title
Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional
Keywords
Constipation, Fiber

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: study+wash out+control
Arm Type
Other
Arm Description
Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks)
Arm Title
Group B: control+wash out+study
Arm Type
Other
Arm Description
Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks)
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixture of fibers + Placebo
Intervention Description
Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo + Mixture of fibers
Intervention Description
Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)
Primary Outcome Measure Information:
Title
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.
Description
Combined score between this parameters
Time Frame
From baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Consistency of stool according to Bristol Stool Form Scale
Description
Valuation of stool characteristics (Bristol scale): 7 types of consistency, where type 1 is the hardest consistency.
Time Frame
From baseline to 8 weeks
Title
Frequency of stool
Description
Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week
Time Frame
From baseline to 8 weeks
Title
Change in stool weight
Description
Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15%
Time Frame
From baseline to 8 weeks
Title
Gastrointestinal symptoms related to the constipation
Description
Record in the patient's dairy all the gastrointestinal symptoms during the study
Time Frame
From baseline to 8 weeks
Title
Adherence record to the complement intake (Moriski Green test)
Description
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.
Time Frame
At 8 weeks
Title
Patient anthropometric measures: weight
Description
Anthropometric records: weight (Kg)
Time Frame
Up to 8 weeks
Title
Patient anthropometric measures: size
Description
Anthropometric records: size (cm)
Time Frame
Up to 8 weeks
Title
Patient anthropometric measures: waist perimeter
Description
Waist perimeter (cm)
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roser De Castellar, MD
Phone
+34 902105243
Email
Roser.DeCastellar@ordesa.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo Rodríguez, MD
Organizational Affiliation
Instituto de Investigación Sanitaria Aragón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud Perpetuo Socorro
City
Huesca
State/Province
Aragon
ZIP/Postal Code
22006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Fuertes, MD
Phone
974 225 450
Facility Name
Centro de Salud Amparo Poch
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50018
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Lostal, MD
Phone
976 547 499
Facility Name
Centro de Salud Isabel II
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Rosa Pardo
Phone
942218161

12. IPD Sharing Statement

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

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