Fiber Use in Pediatric Short Bowel Syndrome - Full Text View

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:

MedlinePlus related topics: Dietary Fiber

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
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

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;
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;
Have increased stool output as manifested by watery stools (3-12/day) and increased ostomy output (20-50 cc/kg/day);
Have not received antibiotics, probiotics or prebiotics for 2 weeks prior to study entry;

Contacts and Locations

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

Locations

United States, Arkansas
Arkansas Children's Hospital	Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Juliana C Frem, MD 501-364-1004 fremjulianac@uams.edu
Principal Investigator: Juliana C Frem, MD

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 18, 2012
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
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013