Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03845673
Other study ID # 0703-457
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2003
Est. completion date July 2005

Study information

Verified date February 2019
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date July 2005
Est. primary completion date July 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Psyllium
Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)
Bowel recipe
consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.

Locations

Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 frequency of bowel movements number of bowel movements per week 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Recruiting NCT06292949 - Clinical Study of Resistant Starch in Improving Constipation N/A
Recruiting NCT04132661 - MRI Assessment of Mode of Action of Bisacodyl, Single Dose Phase 4
Terminated NCT02839889 - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) Phase 4
Completed NCT02726295 - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study Phase 4
Recruiting NCT02255747 - Anal Dilatation for Infants and Children With Constipation N/A
Completed NCT02246647 - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed NCT01566409 - Maintenance Treatment for Children With Constipation N/A
Completed NCT02863848 - Effect of Inulin-type Fructans on Constipated Children. N/A
Completed NCT02658201 - Ultrafast MRI Imaging to Exclude Constipation N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Completed NCT01695915 - Diurnal Variation in Rectal Diameter N/A
Completed NCT01411501 - Efficacy and Safety of Acupuncture for Functional Constipation Phase 3
Completed NCT01438567 - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy Phase 3
Completed NCT01474499 - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation Phase 3
Completed NCT00931853 - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC). Phase 3
Completed NCT01170039 - The Effectiveness of Lubiprostone in Constipated Diabetics Phase 4
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4
Completed NCT00994851 - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment. Phase 3