Fiber Regimens for Constipation Symptoms

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: Bowel recipe; Dietary Supplement: Psyllium

• Registration Number: NCT03845673
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2011-08-02
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-14
• Last Update Submitted: 2019-02-14
• Study First Posted: 2019-02-19
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bowel recipe	Bowel recipe	This group was administered a specialized bowel recipe for 6 weeks
Psyllium	Psyllium	This group of patients was given psyllium for 6 weeks

Primary Outcome Measures

Name	Time	Method
Constipation questionnaire scores	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.

Secondary Outcome Measures

Name	Time	Method
frequency of bowel movements	6 weeks	number of bowel movements per week

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States