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Investigation of Supra Fiber in the Treatment of Adults With Constipation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288508
First Posted: February 2, 2011
Last Update Posted: September 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Satish Rao, Georgia Regents University
  Purpose

Background: Whether Supra-Fiber, a plum-derived fiber supplement is useful in the treatment of constipation is not known. Supra Fiber is the first fiber supplement that has a blend of whole food fruit as its main ingredient. It contains prunes, pomegranates, blueberries, and Acai berries. Unlike psyllium, which is mostly (90%) insoluble fiber, Supra Fiber is a balanced (50%) blend of insoluble and soluble fiber. This may provide the beneficial effects of fiber, and eliminate potential adverse symptoms of fiber such as bloating, distention, hard bulky stools and excess gas. In this study, we expect to not only evaluate the efficacy but also the palatability and tolerability of Supra Fiber in the treatment of chronic constipation.

Aims:

  1. To investigate and compare the effects of Supra Fiber (5 grams BID) or psyllium (5 grams BID) on the number of complete spontaneous bowel movements per week, and bowel symptoms.
  2. To examine the effects of fiber supplements on taste and quality of life in adults with functional chronic constipation in a randomized, double-blind, parallel group controlled trial.

Methods: We propose to enroll 90 subjects with functional constipation in a single blinded, randomized, cross-over study comparing 4 weeks of Supra Fiber with 4 weeks of treatment with Psyllium

Data analysis: The primary outcome measure will be the global relief of constipation symptoms as rated by the subject at the end of each phase of the study. Additionally, we will assess several secondary outcome measures that will include the number of Complete Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient rating of constipation-related symptoms.

Expected results: We anticipate that treatment with Supra Fiber will improve symptoms of constipation compared to the baseline. This improvement will be comparable or superior to that achieved with psyllium treatment. Additionally, Supra Fiber will offer a natural, food based, convenient and more tasty alternative to over-the-counter laxatives and fiber supplements.


Condition Intervention
Constipation Dietary Supplement: Supra Fiber Dietary Supplement: Psyllium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Supra Fiber in the Treatment of Adults With Constipation-A Double-blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Satish Rao, Georgia Regents University:

Primary Outcome Measures:
  • Number of Complete Spontaneous Bowel Movements (CSBM) per week [ Time Frame: 9 Weeks ]
    1. Number of Complete Spontaneous Bowel Movements (CSBM) per week. This will be analyzed from the daily stool diaries (Appendix 1). The CSBM provides a more robust and better assessment of the overall change in bowel function that takes into account not only the stool frequency but also the completeness and satisfaction with bowel function. A CSBM is defined as a bowel movement that is produced without the use of additional laxatives, suppositories or enemas in the previous 24 hours, other than the study medication.


Secondary Outcome Measures:
  • Global Relief of Constipation [ Time Frame: 9 Weeks ]
    1. Global relief of constipation.
    2. Other Parameters of bowel function including stool frequency, stool consistency (Bristol Stool Scale), Straining effort, Feeling of complete evacuation, bloating, and distension


Enrollment: 89
Study Start Date: October 2010
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supra Fiber Dietary Supplement: Supra Fiber
2 tablespoons of fiber taken with 8oz water taken twice a day for 30 days
Active Comparator: Psyllium Dietary Supplement: Psyllium
1 tablespoon of fiber taken with 8 oz water twice a day for 30 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Constipation as defined by Rome III criteria (3,4). Also, patients should have insufficient criteria for IBS, and only rarely experience loose stools without the use of laxatives.
  • Adults between the ages of 18-75 years

Exclusion Criteria:

  • Patients taking drugs that are known to be constipating will be excluded or asked to discontinue medications for at least 2 weeks and reassessed. Patients who remain constipated will be eligible for enrollment.
  • Co-morbid illnesses such as severe cardiovascular disease, chronic renal failure
  • Previous gastrointestinal surgery except cholecystectomy and appendectomy.
  • Neurologic diseases such as multiple sclerosis, strokes, spinal cord injuries, and those who have problems with cognizance, i.e. a mini-mental score of <15 and/or are legally blind
  • Hirschsprung' s disease, or active local anorectal problems such as anal fissures, bleeding hemorrhoids,
  • Alternating constipation and diarrhea and those who fulfill the Rome-III criteria for irritable bowel syndrome.
  • Subjects with a known allergy to psyllium or plums.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288508


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Augusta University
  More Information

Responsible Party: Satish Rao, Professor, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01288508     History of Changes
Other Study ID Numbers: Supra Fiber
First Submitted: January 19, 2011
First Posted: February 2, 2011
Last Update Posted: September 17, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals