Clinical trial NCT04516213: Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: GI Intolerance
timeFrame: 7 Days
Secondary outcomes:
measure: Adverse Events
timeFrame: 7 Days
measure: Energy Requirements Met
timeFrame: 7 Days
measure: Change in Weight
timeFrame: 7 Days
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Children's Center for GI and Nutrition
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: Salt Lake City
country: United States
facility: University of Utah Health Care - Huntsman Cancer Institute (HCI)
state: Utah
Study officials:
affiliation: Children's Center for GI and Nutrition
name: Gerard Minor, MMS, PA-C
role: PRINCIPAL_INVESTIGATOR
References: