Fiber Use in Pediatric Short Bowel Syndrome

Soluble Fiber Use in Pediatric Short Bowel Syndrome

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

Study Overview

• Status: Withdrawn
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Dietary supplement: guar gum

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Benefiber

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Soluble fiber supplementation will improve enteral energy intake of infants with SBS	4 weeks

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: Baylor College of Medicine; USDA Grand Forks Human Nutrition Research Center
• Investigators: Principal Investigator: Juliana C Frem, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): January 15, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Pediatrics, short bowel syndrome, soluble fiber
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: CUMG-108061