Safety & Efficacy Study

Clinical Trial Description

Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants. ;

Study Design

Related Conditions & MeSH terms

Infant Term Birth

See also
Status	Clinical Trial	Phase
Completed	`NCT03710551` - Happy Smooth Study	N/A
Completed	`NCT02598817` - Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
Completed	`NCT03387124` - Breastfeeding Study

See also

Status

Clinical Trial

Phase

Completed

NCT03710551 - Happy Smooth Study

N/A

Completed

NCT02598817 - Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula

Completed

NCT03387124 - Breastfeeding Study

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02670863
Study type	Interventional
Source	Nestlé
Contact
Status	Completed
Phase	N/A
Start date	January 21, 2016
Completion date	May 2017

Safety and Efficacy Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms