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

Not Applicable

Completed

• Conditions: Enteral Nutrition
• Interventions: Other: Enteral Formula With (PHGG)

• Registration Number: NCT04516213
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-28
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-18
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enteral formula tube feeding	Enteral Formula With (PHGG)	Enterally fed children, ages 1-4, with established enteral feeding access

Primary Outcome Measures

Name	Time	Method
GI Intolerance	7 Days	Occurrence of gastrointestinal intolerance (yes/no)

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Riley Children's Hospital; 🇺🇸 Indianapolis, Indiana, United States

The University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Children's Center for GI and Nutrition; 🇺🇸 Hollywood, Florida, 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, United States