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COMPLETED NA

Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

NCT03884309 · View on ClinicalTrials.gov ↗

Study Summary

This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.

Conditions Studied

Interventions

  • OTHER Experimental Hydrolyzed Protein Infant Formula

Study Locations (6)

Texas

  • Ventavia Research Group, LLC — Houston
  • DCOL Center for Clinical Research — Longview

Georgia

  • Paramount Research Solutions — College Park

Kentucky

  • Michael W. Simon, M.D., PSC — Nicholasville

Nebraska

  • Midwest Children's Health Research Institute — Lincoln

Tennessee

  • Memphis & Shelby County Pediatric Group — Memphis

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2019-03-25
Est. Completion 2020-01-07
Phase NA

Sponsor

Abbott Nutrition

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03884309

The ClinicalTrials.gov registry entry for NCT03884309 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Nutrition, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Protein Intolerance appearing as the primary indexed condition, and to 1 intervention — of which Experimental Hydrolyzed Protein Infant Formula is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03884309 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, Georgia, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03884309 about?

NCT03884309 is a clinical study titled "Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula". This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.

What is the current status of trial NCT03884309?

This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2019-03-25. Estimated completion is 2020-01-07.

What conditions does trial NCT03884309 study?

This clinical trial studies the following conditions: Protein Intolerance. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03884309?

The interventions under investigation include: Experimental Hydrolyzed Protein Infant Formula (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03884309?

This trial is sponsored by Abbott Nutrition, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03884309 being conducted?

This trial has 6 study locations across Georgia, Kentucky, Nebraska, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial