Status:
COMPLETED
Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG)
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Enteral Nutrition
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tu...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent from subject and/or subject's parents or legally authorized representatives (LAR).
- Male or female, 12 to 48 months of age, inclusive.
- Subjects requiring enteral feeding for \> 7 days (in hospital, long-term care facility or at home).
- Subjects receiving enteral tube-feeding (nasogastric feeding tube or percutaneous endoscopic gastrostomy \[PEG\] tube) to provide 90% or more of their nutritional needs at the time of study entry.
- Subject is clinically stable (i.e. absence of any significant gastrointestinal symptoms during the past 7 days), in the opinion of the investigator.
Exclusion
- Subjects receiving partial or total parenteral nutrition (e.g. for short bowel syndrome and other causes of intestinal failure).
- Subjects with ongoing or intermittent significant gastrointestinal symptoms during the 7 days before enrollment.
- Oncology patients recovering from chemotherapy or radiotherapy for hematological malignancies or solid tumors (last treatment within 3 months of enrollment).
- Congenital immunodeficiency syndromes (SCID etc).
- Cystic fibrosis and other causes of fat malabsorption (lymphatic malformations/lymphangiectasis).
- Subjects with any clinically significant condition (e.g. severe malnutrition, congenital heart disease, etc) that, in the investigator's opinion, would preclude inclusion in the study.
- Subjects at risk for poor compliance to the study protocol in the investigator's opinion.
- Currently participating in another conflicting trial or participated in an investigational trial within 30 days of enrollment.
- Known hypersensitivity to PHGG or to any other ingredients in the investigational product.
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04516213
Start Date
February 28 2020
End Date
June 1 2021
Last Update
October 15 2024
Active Locations (5)
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1
Children's Center for GI and Nutrition
Hollywood, Florida, United States, 33021
2
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
3
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
4
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108