Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydr… (NCT04516213) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG)
United States24 participantsStarted 2020-02-28
Plain-language 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 Tube-fed Children Aged 1-4 Years over a 7 day period.
Who can participate
Age range1 Year – 4 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 investi…