Fiber Use in Pediatric Short Bowel Syndrome

Arkansas Children's Hospital Research Institute

Status: Withdrawn

Conditions: Short Bowel Syndrome

Treatments: Dietary Supplement: guar gum

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00922805

CUMG-108061

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 2 weeks to 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

fiber-enriched formula then fiber-free formula

Active Comparator group

Description:

Subjects first receive a fiber-enriched formula for one week but then will be crossed over and receive a fiber-free formula

Treatment:

Dietary Supplement: guar gum

fiber-free formula then fiber-enriched formula

Active Comparator group

Description:

Subjects receive first formula only then will be crossed over and receive a fiber-enriched formula

Treatment:

Dietary Supplement: guar gum