Fiber Regimens for Constipation Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-07-31

Brief Summary

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The objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.

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Detailed Description

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Patients presenting to the urogynecology clinics at Parkland Health and Hospital System and UT Southwestern Medical Center at Dallas from July 2003 to July 2005 were screened for symptoms of constipation. Subjects were randomized to a 6-week course of either psyllium (Konsyl, Konsyl Pharmaceuticals, Easton, MD) or a special bowel recipe. The bowel recipe was a modification of that used by Behm and consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice. A validated constipation scoring questionnaire12 was administered to participants at the beginning and at the end of the six-week study period. During the six-week trial patients also kept a bowel diary recording characteristics of each bowel movement.

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psyllium

This group of patients was given psyllium for 6 weeks

Group Type EXPERIMENTAL

Psyllium

Intervention Type DIETARY_SUPPLEMENT

Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)

Bowel recipe

This group was administered a specialized bowel recipe for 6 weeks

Group Type EXPERIMENTAL

Bowel recipe

Intervention Type DIETARY_SUPPLEMENT

consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.

Interventions

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Psyllium

Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)

Intervention Type DIETARY_SUPPLEMENT

Bowel recipe

consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* fluent and literate in either English or Spanish.
* responds affirmatively to at least two symptoms according to Rome II criteria for functional constipation, for at least 12 weeks

Exclusion Criteria

* pregnant or less than six weeks postpartum
* six weeks post abdominal surgery,
* colostomy
* history of bowel obstruction, inflammatory bowel disease, diagnosis of slow colonic transit time, spinal cord injury, neurogenic disease, myopathic disorders, or cognitive impairment, history of an allergic reaction to psyllium or any of the ingredients contained in the bowel recipe, such as wheat bran, prunes, or apples.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes