Fiber Use in Pediatric Short Bowel Syndrome

NCT00922805 | Withdrawn

• 1 other identifier: CUMG-108061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Short Bowel Syndrome

Keywords

Pediatrics, short bowel syndrome, soluble fiber

Outcome Measures

Primary Outcomes (1)

• Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS

  4 weeks

Secondary Outcomes (1)

• Soluble fiber supplementation will improve enteral energy intake of infants with SBS

  4 weeks

Study Arms (2)

fiber-enriched formula then fiber-free formula

ACTIVE COMPARATOR

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

fiber-free formula then fiber-enriched formula

ACTIVE COMPARATOR

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

Dietary Supplement: guar gum

Interventions

guar gum DIETARY_SUPPLEMENT

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

Also known as: Benefiber

fiber-enriched formula then fiber-free formula; fiber-free formula then fiber-enriched formula

Eligibility Criteria

• Age: 2 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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;

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• USDA Grand Forks Human Nutrition Research Center: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

guar gum

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juliana C Frem, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

US (1)