NCT04516213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

August 13, 2020

Last Update Submit

October 11, 2024

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • GI Intolerance

    Occurrence of gastrointestinal intolerance (yes/no)

    7 Days

Secondary Outcomes (3)

  • Adverse Events

    7 Days

  • Energy Requirements Met

    7 Days

  • Change in Weight

    7 Days

Study Arms (1)

Enteral formula tube feeding

EXPERIMENTAL

Enterally fed children, ages 1-4, with established enteral feeding access

Other: Enteral Formula With (PHGG)

Interventions

Enteral Formula With (PHGG)OTHER

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

Enteral formula tube feeding

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Center for GI and Nutrition

Hollywood, Florida, 33021, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of Utah Health Care - Huntsman Cancer Institute (HCI)

Salt Lake City, Utah, 84113-1125, United States

Location

Related Publications (1)

  • Minor G, Sentongo T, Heine RG, Zemrani B. Tolerability and safety of a semi-elemental enteral formula with partially hydrolyzed guar gum (PHGG) in tube-fed children aged 1-4 years: An open-label, single-arm study. Clin Nutr ESPEN. 2023 Jun;55:392-399. doi: 10.1016/j.clnesp.2023.04.004. Epub 2023 Apr 21.

    PMID: 37202073DERIVED

Study Officials

  • Gerard Minor, MMS, PA-C

    Children's Center for GI and Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 18, 2020

Study Start

February 28, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(5)