NCT02193997

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

2.1 years

First QC Date

June 24, 2014

Last Update Submit

September 26, 2017

Conditions

Functional Constipation in Children

Outcome Measures

Primary Outcomes (2)

  • Change in stool frequency

    4 weeks

  • Change in stool consistency

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

    4 weeks

Study Arms (3)

Fiber 1

EXPERIMENTAL

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

Other: Fiber

Fiber 2

EXPERIMENTAL

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

Other: Fiber

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

FiberOTHER
Also known as: Single fiber type
Fiber 1
PlaceboOTHER
Placebo

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age with functional constipation as defined based on the Rome III criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Warren Bishop, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 24, 2014

First Posted

July 18, 2014

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

US(1)