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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01155414
Other study ID # AK75
Secondary ID
Status Completed
Phase Phase 3
First received June 28, 2010
Last updated October 31, 2011
Start date March 2010
Est. completion date July 2010

Study information

Verified date November 2010
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 8 Days
Eligibility Inclusion Criteria:

- Singleton full term birth in good health

- Birth weight was > 2490 g.

- Between 0 and 8 days of age.

- Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.

- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.

- Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria:

• An adverse maternal, fetal or infant medical history and treatment with antibiotics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Hydrolysate based infant formula
Infant formula ad lib
Investigational Infant Formula A
Investigational infant formula ad lib
Investigational Infant Formula B
Investigational infant formula ad lib

Locations

Country Name City State
United States Alabama Clinical Therapeutics, LLC Birmingham Alabama
United States MetroHealth Medical Center Cleveland Ohio
United States University of Iowa Coralville Iowa
United States Alabama Clinical Therapeutics, LLC Dothan Alabama
United States Medical Associates Clinic, PC Dubuque Iowa
United States Pediatric Clinical Research Office Hershey Pennsylvania
United States Ohio Pediatric Research Association Huber Heights Ohio
United States The Jackson Clinic, PA Jackson Tennessee
United States Institute of Clinical Research Mayfield Heights Ohio
United States SCORE Physician Alliance St. Petersburg Florida

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary GI tolerance via stool consistency 28 days No
See also
  Status Clinical Trial Phase
Completed NCT02646969 - Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life N/A
Terminated NCT01137877 - Growth and Tolerance of Healthy Term Infants to a New Infant Formula Phase 3
Completed NCT04015050 - Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants. N/A
Completed NCT01497314 - Growth and Safety of a Low Lactose Milk-Based Infant Formula N/A
Terminated NCT02221687 - The Combiotic-Study N/A
Completed NCT00712608 - The Evaluation of Cow's Milk Formula - Study B N/A