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Fiber Regimens for Constipation Symptoms (constipation)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Constipation

Treatments

Dietary Supplement: Bowel recipe
Dietary Supplement: Psyllium

Study type

Interventional

Funder types

Other

Identifiers

NCT03845673
0703-457

Details and patient eligibility

About

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

Full 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.

Enrollment

53 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 2 patient groups

Psyllium
Experimental group
Description:
This group of patients was given psyllium for 6 weeks
Treatment:
Dietary Supplement: Psyllium
Bowel recipe
Experimental group
Description:
This group was administered a specialized bowel recipe for 6 weeks
Treatment:
Dietary Supplement: Bowel recipe

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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