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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Enteral Nutrition

Intervention / Treatment
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* Other: Enteral Formula With (PHGG)


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteral formula tube feeding<br>Enterally fed children, ages 1-4, with established enteral feeding access | Other: Enteral Formula With (PHGG)<br>* Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI Intolerance | Occurrence of gastrointestinal intolerance (yes/no) | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Frequency and nature of adverse events | 7 Days | 
| Energy Requirements Met | The daily percentage of energy requirements | 7 Days | 
| Change in Weight | The change in weight over a 7-day period | 7 Days |