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

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2002

Primary Completion Date

December 31, 2002

Study Completion Date

October 31, 2003

Conditions
Constipation
Interventions
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®)"

Trial Locations (1)

04039-031

Division of Pediatric Gastroenterology UNIFESP, São Paulo

All Listed Sponsors
collaborator

Maria Eugênia Farias Almeida Motta

UNKNOWN

collaborator

Soraia Tahan

UNKNOWN

collaborator

Mauro Batista de Morais

UNKNOWN

lead

Federal University of São Paulo

OTHER

NCT01267370 - Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial | Biotech Hunter | Biotech Hunter