Clinical trial NCT01288508: Investigation of Supra Fiber in the Treatment of Adults With Constipation
Official title: Investigation of Supra Fiber in the Treatment of Adults With Constipation-A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Complete Spontaneous Bowel Movements (CSBM) per week
timeFrame: 9 Weeks
Secondary outcomes:
measure: Global Relief of Constipation
timeFrame: 9 Weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
References: