Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG)

An Open-label, Single-arm Study to Evaluate 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.

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.

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 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.