Enteral Nutrition
Conditions
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 Tube-fed Children Aged 1-4 Years over a 7 day period.
Interventions
OTHEREnteral Formula With (PHGG)
Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 4 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI Intolerance | 7 Days | Occurrence of gastrointestinal intolerance (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 7 Days | Frequency and nature of adverse events |
| Energy Requirements Met | 7 Days | The daily percentage of energy requirements |
| Change in Weight | 7 Days | The change in weight over a 7-day period |
Countries
United States
Outcome results
None listed