Fiber Regimens for Constipation Symptoms

University of Texas Southwestern Medical Center53 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Constipation

Interventions

PsylliumDIETARY_SUPPLEMENT

Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)

Bowel recipeDIETARY_SUPPLEMENT

consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Secondary Outcomes

frequency of bowel movements

number of bowel movements per week

Time frame: 6 weeks

Data from ClinicalTrials.gov

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