Fiber Regimens for Constipation Symptoms (constipation)

• ClinicalTrials.gov Identifier: NCT03845673
• Recruitment Status: Completed
• First Posted: February 19, 2019
• Last Update Posted: February 19, 2019
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by: University of Texas Southwestern Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Constipation	Dietary Supplement: Psyllium; Dietary Supplement: Bowel recipe	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial Comparing Two Fiber Regimens for the Reduction of Symptoms of Constipation
• Study Start Date: July 2003
• Actual Primary Completion Date: July 2005
• Actual Study Completion Date: July 2005

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Constipation questionnaire scores [ Time Frame: 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 :

1. frequency of bowel movements [ Time Frame: 6 weeks ]
   number of bowel movements per week

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

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

More Information

• Responsible Party: Clifford Wai, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03845673
• Other Study ID Numbers: 0703-457
• First Posted: February 19, 2019
• Last Update Posted: February 19, 2019
• Last Verified: February 2019

Keywords provided by University of Texas Southwestern Medical Center:

Bowel recipe; Bristol stool form scale; Konsyl; psyllium; wheat bran

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive; Psyllium; Cathartics; Gastrointestinal Agents