Functional Constipation in Children
Conditions
Brief summary
This study examines the effects of dietary fiber in the treatment of functional childhood constipation.
Detailed description
This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency. All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.
Interventions
OTHERFiber
OTHERPlacebo
Sponsors
Warren Bishop
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* 2-16 years of age with functional constipation as defined based on the Rome III criteria
Exclusion criteria
* Constipation attributable to organic and anatomic causes or intake of medication * Children who had previous surgery of the colon or anus * History of allergy/intolerance to components of snack bar (e.g. celiac disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool frequency | 4 weeks | — |
| Change in stool consistency | 4 weeks | Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end |
Countries
United States
Outcome results
None listed