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Hydrolyzed protein infant formula with oligosaccharides for Gastrointestinal Tolerance
Study Summary
This trial is testing an infant formula to see if it is effective and safe.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have already been given a special type of nutrition formula made from amino acids.You are currently taking steroids in pill or inhaler form.The pregnant mother is suspected of using harmful substances like alcohol or drugs.You have a medical history that could potentially affect your growth or development, or that of your baby if you are pregnant.If you are a baby who is being fed formula, and you are having trouble digesting it or showing signs of a possible food allergy, or if your doctor has recommended a special formula for your specific condition, you may not be eligible for the study.
- Group 1: Experimental Product
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this study have an age limit?
"The recruitment process for this clinical trial is targeting patients that are less than 90 days old and more than 0 days old."
To whom does this research pertain?
"This trial is looking for 30 participants who have a tolerance to drugs and are aged 0 days to 90 days. The ideal candidate should meet the following criteria: They must be formula-fed, experiencing symptoms of persistent feeding intolerance or food protein allergy, and currently consuming an extensively hydrolyzed formula (EHF) for these symptoms or other conditions where EHF is deemed appropriate by their health care professional. Additionally, parents of infants enrolled in this study must confirm that they will not administer any prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance"
In how many different medical facilities is this research project being conducted currently?
"Meridian Clinical Research, LLC in Washington, Meridian Clinical Research 3357 in Charleston, and Gulf Bank Medical Center in Houston are 3 of the 5 locations where this trial is currently taking place."
How many individuals are enrolling in this research project?
"This study requires 30 individuals that match the given inclusion criteria. Those willing to take part in this research can do so at Meridian Clinical Research, LLC (Washington, District of Columbia) or Meridian Clinical Research 3357 (Charleston, South carolina)."
Are potential participants currently being accepted for this trial?
"According to the website clinicaltrials.gov, this research is currently looking for volunteers. The listing was first put up on May 7th, 2022 and most recently edited on June 23rd of the same year."
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