Fiber Use in Pediatric Short Bowel Syndrome | NCT00922805

Studies
Fiber Use in Pediatric Short Bowel Syndrome

NCT00922805

Sponsor

Arkansas Children's Hospital Research Institute

Status

Withdrawn

Last Update Posted

Jan 15, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Short Bowel Syndrome

Interventions

guar gum

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Jun 16, 2009

First Submission Date that Met QC Criteria

Jun 16, 2009

First Posted Date

Jun 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2014

Last Update Posted Date

Jan 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Arkansas Children's Hospital Research InstituteOTHER

Collaborators

Name	Class
USDA Grand Forks Human Nutrition Research Center	FED
Baylor College of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
guar gum	Dietary Supplement	guar gum (20 g/l of formula) for one week	fiber-enriched formula then fiber-free formula fiber-free formula then fiber-enriched formula

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juliana C Frem, MD	University of Arkansas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital		Little Rock	Arkansas	72202	United States

Condition Browse Module

MeSH Terms

ID	Term
D012778	Short Bowel Syndrome

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C007894	guar gum

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided