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

Completed · Not applicable

Conditions studied: Enteral Nutrition

In brief

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.

Key facts

Study ID

NCT04516213

Run by

Société des Produits Nestlé (SPN)

People needed

24

Starts

2020-02-28

Expected to finish

2021-06-01

Last updated by the study team

2024-10-15

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Center for GI and Nutrition — Hollywood, Florida, United States
• The University of Chicago Medicine — Chicago, Illinois, 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, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.