Fiber Use in Pediatric Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

Official title:

Soluble Fiber Use in Pediatric Short Bowel Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00922805
• Other study ID #: CUMG-108061
• Status: Withdrawn
• Phase: N/A
• First received: June 16, 2009
• Last updated: January 14, 2014
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2014
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• guar gum
guar gum (20 g/l of formula) for one week

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	Baylor College of Medicine, USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS		4 weeks	No
Secondary	Soluble fiber supplementation will improve enteral energy intake of infants with SBS		4 weeks	No