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Dietary Fiber Mixture in Constipated Pediatric Patients

NCT01333787 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2011-04-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Mauro Batista de Morais

    collaborator UNKNOWN

  • Soraia Tahan

    collaborator UNKNOWN

  • Mauro Sérgio Toporovski

    collaborator UNKNOWN

  • Clarice Blaj Neufeld

    collaborator UNKNOWN

  • Thabata Koester Weber

    collaborator UNKNOWN

  • Federal University of São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-01-31
Completion
2010-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01333787 on ClinicalTrials.gov