- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333787
Dietary Fiber Mixture in Constipated Pediatric Patients (MIXFIBER)
A Controlled, Randomized, Double-blind Trial to Evaluate the Effect of a Dietary Fiber Mixture During Maintenance Treatment and on Colonic Transit Time in Constipated Pediatric Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 04039-031
- UNIFESP - Pediatric Gastroenterology Ambulatory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children aged between 4 and 12 years;
- Maintenance treatment using low dose of laxative;
- A family with the socio-economic culture that would make it possible to carry out the procedures of the study's protocol.
Exclusion Criteria:
- Children with organic cause constipation such as Hirschsprung disease, cerebral paralysis, anorectal and spinal medulla abnormalities and metabolic illnesses;
- The regular use of a fiber supplement during the 4 weeks prior to admission;
- The use of medications that would cause constipation;
- Absence of a fixed or mobile telephone in order to make contact.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Dietary Fiber Mixture
The dietary fiber mixture was composed of six different types of fibers.
It was used for treatment of chronic constipation in children.
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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.
Other Names:
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PLACEBO_COMPARATOR: Maltodextrine
Blinded control group
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response - Therapeutic success
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequent daily evacuations, format and consistency of the feces, total and segmental transit time
Time Frame: 4 weeks
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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). |
4 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FiberCCF - EPM2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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