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NCT02401217 · ClinicalTrials.gov registry record · NA
Tolerance of Healthy Infants Fed Infant Formulas
A NA study of Gastrointestinal Tolerance, sponsored by Abbott Nutrition.
- Completed
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 6
- Study locations
NCT02401217: Completed NA study of Gastrointestinal Tolerance, sponsored by Abbott Nutrition.
NCT02401217 is a NA study of Gastrointestinal Tolerance that has completed, run by Abbott Nutrition. The registered enrollment target is 126 participants, below the 176-participant average among 4 other Gastrointestinal Tolerance trials with a reported enrollment target (28% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02401217, a NA study of Gastrointestinal Tolerance, has completed, sponsored by Abbott Nutrition.
- COMPLETED
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
Primary Outcome
MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard.
Conditions Studied
Interventions
- OTHER Phase 1- Arm 1 Infant Formula
- OTHER Phase 2- Arm 2 Infant Formula
- OTHER Phase 2- Arm 3 Infant Formula
Study Locations (6)
Ohio
- Institute of Clinical Research, LLC - Mayfield Heights
- The Cleveland Pediatric Research Center, LLC - Middleburg Heights
Arizona
- W.O.M.B Watching Over Mothers and Babies - Tucson
Florida
- SCORE Physician Alliance LLC - St. Petersburg
North Carolina
- White Oak Family Physicians DBA/Asheboro Research Associates - Asheboro
Utah
- Tanner Memorial Clinic - Layton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT02401217 record still lists
NCT02401217 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 176-participant average among 4 other Gastrointestinal Tolerance trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Gastrointestinal Tolerance appearing as the primary indexed condition, and to 3 interventions - of which Phase 1- Arm 1 Infant Formula is the first listed.
NCT02401217 lists 6 locations in 5 states (Ohio, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT02401217 about?
NCT02401217 is a clinical study titled "Tolerance of Healthy Infants Fed Infant Formulas". The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
What is the current status of trial NCT02401217?
This trial is currently completed. It is a NA study. The enrollment target is 126 participants. The study started on 2015-04. Estimated completion is 2015-09.
What conditions does trial NCT02401217 study?
This clinical trial studies the following conditions: Gastrointestinal Tolerance.
What interventions are being tested in trial NCT02401217?
The interventions under investigation include: Phase 1- Arm 1 Infant Formula (OTHER), Phase 2- Arm 2 Infant Formula (OTHER), Phase 2- Arm 3 Infant Formula (OTHER).
Who is sponsoring clinical trial NCT02401217?
This trial is sponsored by Abbott Nutrition, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02401217 being conducted?
This trial has 6 study locations across Arizona, Florida, North Carolina, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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