The objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.
Full Title of Study: “Randomized Trial Comparing Two Fiber Regimens for the Reduction of Symptoms of Constipation”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2005
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.
- Dietary Supplement: Psyllium
- Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)
- Dietary Supplement: Bowel recipe
- consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.
Arms, Groups and Cohorts
- Experimental: Psyllium
- This group of patients was given psyllium for 6 weeks
- Experimental: Bowel recipe
- This group was administered a specialized bowel recipe for 6 weeks
Clinical Trial Outcome Measures
- Constipation questionnaire scores
- Time Frame: 6 weeks
- 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.
- frequency of bowel movements
- Time Frame: 6 weeks
- number of bowel movements per week
Participating in This Clinical Trial
- 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
- pregnant or less than six weeks postpartum
- six weeks post abdominal surgery,
- 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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Provider of Information About this Clinical Study
- Clifford Wai, University of Texas Southwestern Medical Center
- Overall Official(s)
- Clifford Y Wai, MD, Principal Investigator, University of Texas Southwestern Medical Center
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.