Fiber Regimens for Constipation Symptoms

Study Overview
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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.

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.

Official Title
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Randomized Trial Comparing Two Fiber Regimens for the Reduction of Symptoms of Constipation

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Psyllium
* Dietary Supplement: Bowel recipe


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psyllium<br>This group of patients was given psyllium for 6 weeks | Dietary Supplement: Psyllium<br>* Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)<br>|
| Experimental: Bowel recipe<br>This group was administered a specialized bowel recipe for 6 weeks | Dietary Supplement: Bowel recipe<br>* consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation questionnaire scores | A validated constipation scoring questionnaire was administered to participants at the beginning and at the end of the 6-week study period. Previous studies have shown that dietary modifications can result in significant improvement in constipa- tion scores and symptom relief as early as 2 to 6 weeks. The questionnaire consisted of 8 variables: (i) frequency of bowel movements, (ii) painful evacuation, (iii) incomplete evacuation, (iv) abdominal pain, (v) length of time per attempt, (vi) assis- tance with defecation, (vii) unsuccessful attempts at evacuation per 24 hours, and (viii) duration of constipation. Each variable was scored on a range of 0 to 4 (except for ''assistance for defecation,'' which was scored from 0 to 2), and a cumulative score was determined. A global score of 0 is generally considered normal, and a maximum score of 30 indicates severe con- stipation. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of bowel movements | number of bowel movements per week | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel recipe, Bristol stool form scale, Konsyl, psyllium, wheat bran