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Completed

NCT Number: NCT02193997

Constipation Fiber Trial

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

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Key information

Conditions

Functional Constipation in Children

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fiber

Other

Other names: Single fiber type

Placebo

Other

Primary outcomes

  1. Change in stool frequency

    Time frame: 4 weeks

  2. Change in stool consistency

    Time frame: 4 weeks

    Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end

Sponsors and collaborators

Lead sponsor

Warren Bishop

Other

Registry information

Official study title

Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2014
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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