View Clinical Trial (Medical Research Study)
Investigation of Supra Fiber in the Treatment of Adults With Constipation-A Double-blind Randomized Controlled Trial
| City: |
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52246 |
| Conditions: |
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Constipation |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01288508 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Iowa City, Iowa 52246
United States
Satish SC Rao, MD
Phone: 319-353-6602
Email: satish-rao@uiowa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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