Clinical trial NCT00922805: Fiber Use in Pediatric Short Bowel Syndrome
Official title: Soluble Fiber Use in Pediatric Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Short Bowel Syndrome
Keywords: Pediatrics, short bowel syndrome, soluble fiber
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: USDA Grand Forks Human Nutrition Research Center
name: Baylor College of Medicine
First posted: 2009-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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;

Primary outcomes:
measure: Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS
timeFrame: 4 weeks
Secondary outcomes:
measure: Soluble fiber supplementation will improve enteral energy intake of infants with SBS
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Juliana C Frem, MD
role: PRINCIPAL_INVESTIGATOR
References: