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

Enteral Nutrition Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516213
• Other study ID #: 19.02.CLI
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago Medicine	Chicago	Illinois
United States	Children's Center for GI and Nutrition	Hollywood	Florida
United States	Riley Children's Hospital	Indianapolis	Indiana
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	University of Utah Health Care - Huntsman Cancer Institute (HCI)	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI Intolerance	Occurrence of gastrointestinal intolerance (yes/no)	7 Days
Secondary	Adverse Events	Frequency and nature of adverse events	7 Days
Secondary	Energy Requirements Met	The daily percentage of energy requirements	7 Days
Secondary	Change in Weight	The change in weight over a 7-day period	7 Days