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This study examines the effects of dietary fiber in the treatment of functional childhood constipation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber 1 | Experimental | Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks |
|
| Fiber 2 | Experimental | Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks |
|
| Placebo | Placebo Comparator | Bar with low fiber content (placebo) once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber | Other |
|
| |
| Fiber |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Bishop, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Other |
|
|
| Placebo | Other |
|
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |