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Fiber Use in Pediatric Short Bowel Syndrome

Soluble Fiber Use in Pediatric Short Bowel Syndrome

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00922805
Enrollment
0
Registered
2009-06-17
Start date
2009-01-31
Completion date
2012-01-31
Last updated
2014-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

Keywords

Pediatrics, short bowel syndrome, soluble fiber

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.

Interventions

DIETARY_SUPPLEMENTguar gum

guar gum (20 g/l of formula) for one week

Sponsors

USDA Grand Forks Human Nutrition Research Center
CollaboratorFED
Baylor College of Medicine
CollaboratorOTHER
Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Weeks to 1 Years
Healthy volunteers
No

Inclusion 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;

Design outcomes

Primary

MeasureTime frame
Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS4 weeks

Secondary

MeasureTime frame
Soluble fiber supplementation will improve enteral energy intake of infants with SBS4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026