Constipation Fiber Trial

Warren Bishop

Status: Completed

Conditions: Functional Constipation in Children

Treatments: Other: Placebo; Other: Fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT02193997

201203734

Details and patient eligibility

About

This study examines the effects of dietary fiber in the treatment of functional childhood constipation.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Fiber 1

Experimental group

Description:

Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks

Treatment:

Other: Fiber

Other: Fiber

Fiber 2

Experimental group

Description:

Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks

Treatment:

Other: Fiber

Other: Fiber

Placebo

Placebo Comparator group

Description:

Bar with low fiber content (placebo) once daily for 4 weeks

Treatment:

Other: Placebo