An interventional study of Psyllium and Bowel recipe in Constipation, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
The objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 53 is below the median of 80 across 850 interventional studies indexed under Constipation.
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Exclusion Criteria:
This group of patients was given psyllium for 6 weeks
Dietary Supplement: Psyllium
This group was administered a specialized bowel recipe for 6 weeks
Dietary Supplement: Bowel recipe
Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)
consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.
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.
Time frame: 6 weeks
frequency of bowel movements
number of bowel movements per week
Time frame: 6 weeks
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center