Dietary Fiber Mixture in Constipated Pediatric Patients (MIXFIBER)

This study has been completed.
Sponsor:
Collaborators:
Mauro Batista de Morais
Soraia Tahan
Mauro Sérgio Toporovski
Clarice Blaj Neufeld
Thabata Koester Weber
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01333787
First received: April 11, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the treatment of chronic constipation and on the colonic transit time in children.


Condition Intervention Phase
Constipation
Dietary Supplement: Dietary Fiber Mixture
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled, Randomized, Double-blind Trial to Evaluate the Effect of a Dietary Fiber Mixture During Maintenance Treatment and on Colonic Transit Time in Constipated Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Clinical response - Therapeutic success [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The primary outcome result measurement was the therapeutic success. This therapeutic success was considered when the patient demonstrated daily evacuations or had interposing days of pasty consistency, without pain or difficulty and the absence of fecal incontinence during the 4 weeks of intervention, without the need of using a laxative or rectal enema.


Secondary Outcome Measures:
  • Frequent daily evacuations, format and consistency of the feces, total and segmental transit time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    The format and consistency of the feces was evaluated in accordance with the Bristol Stool Form Scale (stool are rated based on water content of the feces, with 1 meaning hard stools to 7 meaning liquid stools).

    The colonic transit time was evaluated during the study's final week by way of the method proposed by Bouchoucha et al. (1992).



Enrollment: 54
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary Fiber Mixture
The dietary fiber mixture was composed of six different types of fibers. It was used for treatment of chronic constipation in children.
Dietary Supplement: Dietary Fiber Mixture

During the four weeks the patients received fiber mixtures (intervention) or maltodextrine as the placebo. The fiber mixture was composed of six different types of fibers: 10.5% fructooligosaccharides, 12.5% inulin, 24% Arabic gum, 9% resistant starch, 33% Soya polysaccharide e 12% cellulose.

The dose was defined in accordance with the child's body weight: 6.3 grams of fiber supplement, which corresponds to 4.8 g of fiber, or placebo(1 table spoon) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing up to 18 kg; 12.6 grams of fiber supplement, which corresponds to 9.6 g of fiber, or placebo (2 table spoons) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing more than 18 Kg.

Other Name: Stimulance
Placebo Comparator: Maltodextrine
Blinded control group
Dietary Supplement: Dietary Fiber Mixture

During the four weeks the patients received fiber mixtures (intervention) or maltodextrine as the placebo. The fiber mixture was composed of six different types of fibers: 10.5% fructooligosaccharides, 12.5% inulin, 24% Arabic gum, 9% resistant starch, 33% Soya polysaccharide e 12% cellulose.

The dose was defined in accordance with the child's body weight: 6.3 grams of fiber supplement, which corresponds to 4.8 g of fiber, or placebo(1 table spoon) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing up to 18 kg; 12.6 grams of fiber supplement, which corresponds to 9.6 g of fiber, or placebo (2 table spoons) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing more than 18 Kg.

Other Name: Stimulance

Detailed Description:

In spite of an increase in the consumption of fibers being indicated for the treatment of constipation, few clinical trails have evaluated its efficiency. In the majority of prior studies only the effect of a single type of fiber was evaluated. Each type of fiber presents a particular characteristic, which determines its action mechanism and performance in different parts of the colon. Therefore, theoretically, greater effectiveness could well be observed when different types of fibers are associated into a single product for fiber supplementation.

A randomized, parallel, double-blind, controlled was performed to evaluate the effect of a dietary fiber mixture in constipated pediatric patients.

Children aged between 4 and 12 years were included in the study and the initial diagnosis of functional chronic constipation was made in accordance with the Rome III criteria. The children having attended the Pediatric Gastroenterology Ambulatory of the Federal University of Sao Paulo and the Santa Casa de Misericórdia hospital in Sao Paulo city. All of the children were undergoing constipation maintenance treatment with the use of a laxative in a dosage less than 1.0 ml/Kg for milk of magnesia, mineral oil or lactulose or less than 0.5 g/Kg for polyethylene glycol 3350.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged between 4 and 12 years;
  • Maintenance treatment using low dose of laxative;
  • A family with the socio-economic culture that would make it possible to carry out the procedures of the study's protocol.

Exclusion Criteria:

  • Children with organic cause constipation such as Hirschsprung disease, cerebral paralysis, anorectal and spinal medulla abnormalities and metabolic illnesses;
  • The regular use of a fiber supplement during the 4 weeks prior to admission;
  • The use of medications that would cause constipation;
  • Absence of a fixed or mobile telephone in order to make contact.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333787

Locations
Brazil
UNIFESP - Pediatric Gastroenterology Ambulatory
Sao Paulo, Brazil, 04039-031
Sponsors and Collaborators
Federal University of São Paulo
Mauro Batista de Morais
Soraia Tahan
Mauro Sérgio Toporovski
Clarice Blaj Neufeld
Thabata Koester Weber
  More Information

No publications provided

Responsible Party: Mauro Batista de Morais, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01333787     History of Changes
Other Study ID Numbers: FiberCCF - EPM2
Study First Received: April 11, 2011
Last Updated: April 11, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
dietary fiber
clinical trial
constipation
children

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014