Fiber Use in Pediatric Short Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-01-31

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

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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.

Conditions

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Short Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

guar gum

Intervention Type DIETARY_SUPPLEMENT

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

fiber-free formula then fiber-enriched formula

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

Group Type ACTIVE_COMPARATOR

guar gum

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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guar gum

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Benefiber

Eligibility Criteria

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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;

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No