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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2021-06-01

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.

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Detailed Description

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Conditions

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Enteral Nutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Enteral formula tube feeding

Enterally fed children, ages 1-4, with established enteral feeding access

Group Type EXPERIMENTAL

Enteral Formula With (PHGG)

Intervention Type OTHER

Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)

Interventions

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Enteral Formula With (PHGG)

Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)

Intervention Type OTHER

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No