Constipation Clinical Trial
— constipationOfficial title:
Randomized Trial Comparing Two Fiber Regimens for the Reduction of Symptoms of Constipation
NCT number | NCT03845673 |
Other study ID # | 0703-457 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2003 |
Est. completion date | July 2005 |
Verified date | February 2019 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.
Status | Completed |
Enrollment | 53 |
Est. completion date | July 2005 |
Est. primary completion date | July 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | frequency of bowel movements | number of bowel movements per week | 6 weeks |
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