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

NCT04028258 | Unknown

• 1 other identifier: VEGY-DOWN (A)-05-17
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Conditions

Constipation - Functional

Keywords

Constipation; Fiber

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Consistency of stool according to Bristol Stool Form Scale

  From baseline to 8 weeks

• Frequency of stool

  From baseline to 8 weeks

• Change in stool weight

  From baseline to 8 weeks

• Gastrointestinal symptoms related to the constipation

  From baseline to 8 weeks

• Adherence record to the complement intake (Moriski Green test)

  At 8 weeks

Study Arms (2)

Group A: study+wash out+control

OTHER

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

Dietary Supplement: Mixture of fibers + Placebo

Group B: control+wash out+study

OTHER

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

Dietary Supplement: Placebo + Mixture of fibers

Interventions

Mixture of fibers + Placebo DIETARY_SUPPLEMENT

Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)

Group A: study+wash out+control

Placebo + Mixture of fibers DIETARY_SUPPLEMENT

Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)

Group B: control+wash out+study

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys and girls aged 3 to 12
• Diagnosis of functional constipation according to Rome IV criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Ordesa: lead

Study Sites (3)

Centro de Salud Perpetuo Socorro

Huesca, Aragon, 22006, Spain

RECRUITING

Centro de Salud Amparo Poch

Zaragoza, Aragon, 50018, Spain

RECRUITING

Centro de Salud Isabel II

Santander, Cantabria, 39002, Spain

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerardo Rodríguez, MD

  Instituto de Investigación Sanitaria Aragón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roser De Castellar, MD

CONTACT

+34 902105243; Roser.DeCastellar@ordesa.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 22, 2019
• Study Start: February 13, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

ES (3)