Fiber Regimens for Constipation Symptoms (constipation)

Randomized Trial Comparing Two Fiber Regimens for the Reduction of Symptoms of Constipation

The objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Psyllium; Dietary supplement: Bowel recipe

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psyllium; This group of patients was given psyllium for 6 weeks	Dietary supplement: Psyllium; Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)
Experimental: Bowel recipe; This group was administered a specialized bowel recipe for 6 weeks	Dietary supplement: Bowel recipe; consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of bowel movements	number of bowel movements per week	6 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Clifford Y Wai, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: psyllium; wheat bran; Bowel recipe; Bristol stool form scale; Konsyl
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Cathartics; Psyllium
• Other Study ID Numbers: 0703-457