Back to resultsFiber Regimens for Constipation Symptoms (constipation)
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psyllium
Bowel recipe
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Bowel recipe, Bristol stool form scale, Konsyl, psyllium, wheat bran
Eligibility Criteria
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.
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Psyllium
Bowel recipe
Arm Description
This group of patients was given psyllium for 6 weeks
This group was administered a specialized bowel recipe for 6 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
frequency of bowel movements
number of bowel movements per week
Full Information
NCT ID
NCT03845673
First Posted
August 2, 2011
Last Updated
February 14, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03845673
Brief Title
Fiber Regimens for Constipation Symptoms
Acronym
constipation
Official Title
Randomized Trial Comparing Two Fiber Regimens for the Reduction of Symptoms of Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Bowel recipe, Bristol stool form scale, Konsyl, psyllium, wheat bran
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psyllium
Arm Type
Experimental
Arm Description
This group of patients was given psyllium for 6 weeks
Arm Title
Bowel recipe
Arm Type
Experimental
Arm Description
This group was administered a specialized bowel recipe for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium
Intervention Description
Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)
Intervention Type
Dietary Supplement
Intervention Name(s)
Bowel recipe
Intervention Description
consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.
Primary Outcome Measure Information:
Title
Constipation questionnaire scores
Description
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
Secondary Outcome Measure Information:
Title
frequency of bowel movements
Description
number of bowel movements per week
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford Y Wai, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fiber Regimens for Constipation Symptoms
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