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

NCT01267370 | Completed Phase 4

• 1 other identifier: FiberCCF-EPM1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation

Keywords

clinical trial; dietary fiber; constipation; children

Outcome Measures

Primary Outcomes (1)

• Clinical response

  Frequency of stool passage, paiful defecation, stool consistency

  6 weeks

Secondary Outcomes (1)

• total and segmental colonic transit time and fecal weight and moisture

  6 weeks

Study Arms (2)

Soy polysaccharide fiber

ACTIVE COMPARATOR

Dietary fiber for treatment of chronic constipation in children

Dietary Supplement: Soy polysaccharide fiber

purified soy extract, with no fiber)

PLACEBO COMPARATOR

blinded control group

Dietary Supplement: Soy polysaccharide fiber

Interventions

Soy polysaccharide fiber DIETARY_SUPPLEMENT

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®)

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

Soy polysaccharide fiber; purified soy extract, with no fiber)

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Maria Eugênia Farias Almeida Motta: collaborator
• Soraia Tahan: collaborator
• Mauro Batista de Morais: collaborator

Study Sites (1)

Division of Pediatric Gastroenterology UNIFESP

São Paulo, São Paulo, 04039-031, Brazil

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: January 1, 2002
• Primary Completion: December 1, 2002
• Study Completion: October 1, 2003
• Last Updated: December 28, 2010

Record last verified: 2003-10

Locations

BR (1)