Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial (SOYFIBER)

This study has been completed.
Sponsor:
Collaborators:
Maria Eugênia Farias Almeida Motta
Soraia Tahan
Mauro Batista de Morais
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01267370
First received: December 27, 2010
Last updated: NA
Last verified: October 2003
History: No changes posted
  Purpose

The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.


Condition Intervention Phase
Constipation
Dietary Supplement: Soy polysaccharide fiber
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: Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Frequency of stool passage, paiful defecation, stool consistency


Secondary Outcome Measures:
  • total and segmental colonic transit time and fecal weight and moisture [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Colonic transit time was evaluated by the technique of Metcalf et al. In brief, a plain abdominal radiograph performed after 24 hours from the last ingestion of 3 sets of 20 distinctive radio-opaque markers taken on 3 consecutive days. In the presence of > 20% of the markers, a further radiography was taken on the 7th day. The colonic segments were delimitated according to Arhan et al. The patients were instructed to collect the 3-day stools separately from the urine. The collected stools were used to determine the fecal weight and moisture.


Enrollment: 30
Study Start Date: January 2002
Study Completion Date: October 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Soy polysaccharide fiber
Dietary fiber for treatment of chronic constipation in children
Dietary Supplement: Soy polysaccharide fiber

Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.

The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.

Arms: Soy polysaccharide fiber, purified soy extract, with no fiber

Other Names:

Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)

Other Names:
  • Soy polysaccharide fiber (Pró-fibra®)
  • Purified soy extract, with no fiber (Soyac®)
Placebo Comparator: purified soy extract, with no fiber)
blinded control group
Dietary Supplement: Soy polysaccharide fiber

Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.

The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.

Arms: Soy polysaccharide fiber, purified soy extract, with no fiber

Other Names:

Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)

Other Names:
  • Soy polysaccharide fiber (Pró-fibra®)
  • Purified soy extract, with no fiber (Soyac®)

Detailed Description:

The study was performed out at outpatient clinic of Pediatric Gastroenterology at the Federal University of São Paulo (São Paulo, Brazil), located in the southeastern region of Brazil. It is a public referral hospital for pediatric gastroenterology attendance in the Metropolitan area of the São Paulo and in Brazil. In general, the patients go to consultation after a referral from a primary care center.

Study design and sample size The design was a randomized double-blind trial, placebo-controlled study. Sample size was calculated by the formula of comparison of two proportions, using clinical improvement as a primary outcome. It had been previously calculated that a minimum of 14 patients in each group will give a power of 80% to detect a effect size of 50% with significance at the level of 5% (one-sided).

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over two years of age at first consultation and chronic functional constipation were included. Chronic constipation was defined by the occurrence of any of the following, for at least 2 weeks, independently of stool frequency: passage of hard, scybalous, pebble-like or cylindrical cracked stools, straining or painful defecation, passage of large stools that may clog the toilet, or stool frequency less than 3 per week.

Exclusion Criteria:

  • The exclusion criteria applied were organic constipation, regular use of dietary fiber in the preceding 30 days or drugs causing constipation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267370

Locations
Brazil
Division of Pediatric Gastroenterology UNIFESP
São Paulo, Brazil, 04039-031
Sponsors and Collaborators
Federal University of São Paulo
Maria Eugênia Farias Almeida Motta
Soraia Tahan
Mauro Batista de Morais
  More Information

No publications provided

Responsible Party: Mauro Batista de Morais, Universidade Federal de São Paulo
ClinicalTrials.gov Identifier: NCT01267370     History of Changes
Other Study ID Numbers: FiberCCF-EPM1
Study First Received: December 27, 2010
Last Updated: December 27, 2010
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014