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COMPLETED Phase 3

Tolerance of Healthy Term Infants Fed Infant Formulas #3

NCT00977964 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Conditions Studied

Interventions

  • OTHER Experimental milk protein infant formula Process A
  • OTHER Experimental milk protein infant formula Process B
  • OTHER Experimental milk protein infant formula Process C
  • OTHER Experimental milk protein infant formula Process D
  • OTHER Experimental milk protein infant formula Process E

Study Locations (15)

Ohio

  • Pediatric Associates of Mount Carmel, Inc — Cincinnati
  • MetroHealth Medical Center — Cleveland
  • Dayton Clinical Research — Dayton
  • Ohio Pediatric Research Association, Inc. — Huber Heights
  • Institute of Clinical Research — Mayfield Heights

Florida

  • All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc — Plantation
  • SCORE Physician Alliance, LLC — St. Petersburg
  • University of South Florida — Tampa

Alabama

  • Alabama Clinical Therapeutics — Dothan

Georgia

  • North Georgia Clinical Research — Dalton

Indiana

  • Northpoint Pediatrics, LLC — Indianapolis

Iowa

  • Medical Associates Clinic, PC — Dubuque

Kentucky

  • Kentucky Pediatric / Adult Research — Bardstown

Tennessee

  • The Jackson Clinic, PA — Jackson

Trial Details

FieldValue
Enrollment Target 270 participants
Start Date 2009-09
Est. Completion 2010-01
Phase Phase 3

Sponsor

Abbott Nutrition

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00977964

The ClinicalTrials.gov registry entry for NCT00977964 describes a study currently listed as completed. It is categorized as Phase 3, 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 270 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 Gastrointestinal Tolerance appearing as the primary indexed condition, and to 5 interventions — of which Experimental milk protein infant formula Process A 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: NCT00977964 reports 15 study locations spanning 9 distinct geographic areas — top geographies include Ohio, Florida, Alabama. 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 NCT00977964 about?

NCT00977964 is a clinical study titled "Tolerance of Healthy Term Infants Fed Infant Formulas #3". The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

What is the current status of trial NCT00977964?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2009-09. Estimated completion is 2010-01.

What conditions does trial NCT00977964 study?

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

What interventions are being tested in trial NCT00977964?

The interventions under investigation include: Experimental milk protein infant formula Process A (OTHER), Experimental milk protein infant formula Process B (OTHER), Experimental milk protein infant formula Process C (OTHER), Experimental milk protein infant formula Process D (OTHER), Experimental milk protein infant formula Process E (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00977964?

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 NCT00977964 being conducted?

This trial has 15 study locations across Alabama, Florida, Georgia, Indiana, Iowa. 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