Your session is about to expire
← Back to Search
Enteral Formula
Tube Feeding Formula Tolerance in Children
N/A
Recruiting
Led By Jessie Hulst, MD
Research Sponsored by Société des Produits Nestlé (SPN)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Study Summary
This trial tests a formula to check if it is safe and effective for kids.
Who is the study for?
This trial is for medically stable children aged 1 to 13 who are currently tube-fed and rely on it for at least 90% of their nutrition. They must be tolerating their current enteral feeding well and be deemed appropriate candidates for the study formula. Parents or guardians need to give signed consent.Check my eligibility
What is being tested?
The trial is testing a special formulated liquid diet designed for children who receive nutrition through tube feeding. The goal is to evaluate how effective, tolerable, and safe this new pediatric enteral formula is.See study design
What are the potential side effects?
Potential side effects may include digestive issues such as nausea, vomiting, diarrhea or constipation due to the new formula. Allergic reactions could also occur if the child has sensitivities to ingredients in the formula.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nutritional efficacy - energy
Secondary outcome measures
Adverse events
Bristol Stool Chart
Frequency of nausea
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Enteral tube fed childrenExperimental Treatment1 Intervention
Children being fed an enteral formula with a feeding tube
Find a Location
Who is running the clinical trial?
Société des Produits Nestlé (SPN)Lead Sponsor
337 Previous Clinical Trials
62,535 Total Patients Enrolled
2 Trials studying Tube Feeding
50 Patients Enrolled for Tube Feeding
Krys Araujo Torres, MDStudy DirectorNestle Health Science USA
Jessie Hulst, MDPrincipal InvestigatorThe Hospital for Sick Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health issues or take medications that would make the study treatment unsafe for me.I cannot be fed through a tube due to a blockage in my intestines.My child is stable and receives nutrition through a feeding tube.I have used the study product before.I am between 1 and 13 years old.I've been sick recently, affecting my eating for more than 2 days.I rely on tube feeding for most of my nutrition.
Research Study Groups:
This trial has the following groups:- Group 1: Enteral tube fed children
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for me to participate in this research trial?
"Applicants that are between 1 year old and 13 years of age, who have been prescribed tube feeding, can join this clinical trial. There is a total participant limit of 30 individuals."
Answered by AI
Is the enrollment age limit for this research study set at twenty or above?
"According to the parameters of this experiment, patients between 1 year and 13 years old are eligible. Moreover, 4 distinct studies have been created for minors while 5 were designed specifically for seniors aged 65 or more."
Answered by AI
Are there any available slots for participation in this research project?
"According to clinicaltrials.gov, this specific trial is not actively enrolling new patients at the moment. It was first posted on May 1st 2023 and last updated April 28th 2023. However, 8 other medical trials are open and recruiting candidates in the area right now."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger