Fiber Use in Pediatric Short Bowel Syndrome
Primary Purpose
Short Bowel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
guar gum
Sponsored by
About this trial
This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Pediatrics, short bowel syndrome, soluble fiber
Eligibility Criteria
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;
Sites / Locations
- Arkansas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fiber-enriched formula then fiber-free formula
fiber-free formula then fiber-enriched formula
Arm Description
Subjects first receive a fiber-enriched formula for one week but then will be crossed over and receive a fiber-free formula
Subjects receive first formula only then will be crossed over and receive a fiber-enriched formula
Outcomes
Primary Outcome Measures
Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS
Secondary Outcome Measures
Soluble fiber supplementation will improve enteral energy intake of infants with SBS
Full Information
NCT ID
NCT00922805
First Posted
June 16, 2009
Last Updated
January 14, 2014
Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
USDA Grand Forks Human Nutrition Research Center, Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00922805
Brief Title
Fiber Use in Pediatric Short Bowel Syndrome
Official Title
Soluble Fiber Use in Pediatric Short Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
USDA Grand Forks Human Nutrition Research Center, Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Pediatrics, short bowel syndrome, soluble fiber
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fiber-enriched formula then fiber-free formula
Arm Type
Active Comparator
Arm Description
Subjects first receive a fiber-enriched formula for one week but then will be crossed over and receive a fiber-free formula
Arm Title
fiber-free formula then fiber-enriched formula
Arm Type
Active Comparator
Arm Description
Subjects receive first formula only then will be crossed over and receive a fiber-enriched formula
Intervention Type
Dietary Supplement
Intervention Name(s)
guar gum
Other Intervention Name(s)
Benefiber
Intervention Description
guar gum (20 g/l of formula) for one week
Primary Outcome Measure Information:
Title
Soluble fiber supplementation, as a short chain fatty acid precursor, will improve intestinal integrity of infants with SBS
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Soluble fiber supplementation will improve enteral energy intake of infants with SBS
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana C Frem, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
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Fiber Use in Pediatric Short Bowel Syndrome
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