Investigation of Supra Fiber in the Treatment of Adults With Constipation

September 16, 2014 updated by: Satish Rao, Augusta University

Investigation of Supra Fiber in the Treatment of Adults With Constipation-A Double-blind Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
9 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
9 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Supra Fiber

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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