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

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.

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.

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition
• Intervention / Treatment: Other: Enteral Formula With (PHGG)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Children's Center for GI and Nutrition
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113-1125
      • University of Utah Health Care - Huntsman Cancer Institute (HCI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Gerard Minor, MMS, PA-C, Children's Center for GI and Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 19.02.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No