Fiber Use in Pediatric Short Bowel Syndrome

Not Applicable

Withdrawn

• Conditions: Short Bowel Syndrome
• Interventions: Dietary Supplement: guar gum

• Registration Number: NCT00922805
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief 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

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fiber-free formula then fiber-enriched formula	guar gum	Subjects receive first formula only then will be crossed over and receive a fiber-enriched formula
fiber-enriched formula then fiber-free formula	guar gum	Subjects first receive a fiber-enriched formula for one week but then will be crossed over and receive a fiber-free formula

Primary Outcome Measures

Name	Time	Method
Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS	4 weeks

Secondary Outcome Measures

Name	Time	Method
Soluble fiber supplementation will improve enteral energy intake of infants with SBS	4 weeks

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States