Investigation of Supra Fiber in the Treatment of Adults With Constipation

NCT01288508 | Completed

• 1 other identifier: Supra Fiber
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Number of Complete Spontaneous Bowel Movements (CSBM) per week

  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 Outcomes (1)

• Global Relief of Constipation

  9 Weeks

Study Arms (2)

Supra Fiber

ACTIVE COMPARATOR

Dietary Supplement: Supra Fiber

Psyllium

ACTIVE COMPARATOR

Dietary Supplement: Psyllium

Interventions

Supra Fiber DIETARY_SUPPLEMENT

2 tablespoons of fiber taken with 8oz water taken twice a day for 30 days

Supra Fiber

Psyllium DIETARY_SUPPLEMENT

1 tablespoon of fiber taken with 8 oz water twice a day for 30 days

Psyllium

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: February 2, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

US (1)