A Phase 4 interventional study of Dietary Fiber Mixture in Constipation, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2011-04-12.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
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.
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.
1,018 studies on the registry are indexed under Constipation; 140 are open to participants now.
This study's enrollment of 54 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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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
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.
Also known as: Stimulance
Clinical response - Therapeutic success
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.
Time frame: 4 weeks
Frequent daily evacuations, format and consistency of the feces, total and segmental transit time
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).
Time frame: 4 weeks
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo