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Fiber Use in Pediatric Short Bowel Syndrome

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
USDA Grand Forks Human Nutrition Research Center
Baylor College of Medicine
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00922805
First received: June 16, 2009
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies.

Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.

The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS


Condition Intervention
Short Bowel Syndrome
Dietary Supplement: guar gum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Soluble Fiber Use in Pediatric Short Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Soluble fiber supplementation will improve enteral energy intake of infants with SBS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fiber-enriched formula then fiber-free formula
Subjects first receive a fiber-enriched formula for one week but then will be crossed over and receive a fiber-free formula
Dietary Supplement: guar gum
guar gum (20 g/l of formula) for one week
Other Name: Benefiber
Active Comparator: fiber-free formula then fiber-enriched formula
Subjects receive first formula only then will be crossed over and receive a fiber-enriched formula
Dietary Supplement: guar gum
guar gum (20 g/l of formula) for one week
Other Name: Benefiber

Detailed Description:

Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies. As the intestine tries to grow back some of its length, a process that can take many months, these infants become dependent on intravenous (IV) nutrition in order to survive. Liver disease and sepsis (a blood stream infection) are common complications of IV nutrition and are the two most common causes of death in this population. Therefore, clinicians have tried different ways to improve feeding and shorten the amount of time of IV nutrition, for example continuous feedings through the intestine, use of partly digested formulas and change in diet.

Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.

The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Pediatric infants (less than 1 y of age) who

  1. Have Short Bowel Syndrome defined by a history of congenital or surgical loss of intestinal absorptive function resulting in parenteral nutrition dependency of longer than 30 days;
  2. Are receiving at least 20% of their caloric needs from enteral nutrition and have been on enteral nutrition for at least 1 week following intestinal resection;
  3. Have increased stool output as manifested by watery stools (3-12/day) and increased ostomy output (20-50 cc/kg/day);
  4. Have not received antibiotics, probiotics or prebiotics for 2 weeks prior to study entry;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922805

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
USDA Grand Forks Human Nutrition Research Center
Baylor College of Medicine
Investigators
Principal Investigator: Juliana C Frem, MD University of Arkansas
  More Information

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00922805     History of Changes
Other Study ID Numbers: CUMG-108061
Study First Received: June 16, 2009
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Pediatrics, short bowel syndrome, soluble fiber

Additional relevant MeSH terms:
Short Bowel Syndrome
Syndrome
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on November 20, 2014