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

Nestlé

Status

Completed

Conditions

Enteral Nutrition

Treatments

Other: Enteral Formula With (PHGG)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04516213

19.02.CLI

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

1 to 4 years old

Volunteers

No Healthy Volunteers

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.