Fiber Regimens for Constipation Symptoms

NCT03845673 | Completed

• 1 other identifier: 0703-457
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• frequency of bowel movements

  6 weeks

Study Arms (2)

Psyllium

EXPERIMENTAL

This group of patients was given psyllium for 6 weeks

Dietary Supplement: Psyllium

Bowel recipe

EXPERIMENTAL

This group was administered a specialized bowel recipe for 6 weeks

Dietary Supplement: Bowel recipe

Interventions

Psyllium DIETARY_SUPPLEMENT

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

Psyllium

Bowel recipe DIETARY_SUPPLEMENT

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

Bowel recipe

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Clifford Y Wai, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: February 19, 2019
• Study Start: July 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

US (1)