Fiber Use in Pediatric Short Bowel Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Soluble Fiber Use in Pediatric Short Bowel Syndrome

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: guar gum


Participation Criteria
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Eligibility Criteria
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Pediatric infants (less than 1 y of age) who 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; 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; Have increased stool output as manifested by watery stools (3-12/day) and increased ostomy output (20-50 cc/kg/day); Have not received antibiotics, probiotics or prebiotics for 2 weeks prior to study entry;

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fiber-enriched formula then fiber-free formula<br>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<br>* guar gum (20 g/l of formula) for one week<br>* Other names: Benefiber;|
| Active Comparator: fiber-free formula then fiber-enriched formula<br>Subjects receive first formula only then will be crossed over and receive a fiber-enriched formula | Dietary Supplement: guar gum<br>* guar gum (20 g/l of formula) for one week<br>* Other names: Benefiber;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, short bowel syndrome, soluble fiber