Tolerance of Infants Fed a Hydrolysate Formula

Gastrointestinal Tolerance Clinical Trial

Official title:

Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628183
• Other study ID #: AL30
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: November 23, 2018

Study information

• Verified date: December 2018
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Subject is judged to be in good health

• Singleton from a full-term birth

• Birth weight was > or = to 2490 g

• Between 0 and 14 days of age at enrollment

• Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study

• 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

• Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

Exclusion Criteria:

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.

• Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance

• Subject participates in another study that has not been approved as a concomitant study

• Subject has an allergy or intolerance to any ingredient in the study product

• Subject has been treated with antibiotics within 2 weeks prior to enrollment

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Hydrolysate Infant Formula 1
Feed ad lib
• Hydrolysate Infant Formula 2
Feed ad lib

Locations

Country	Name	City	State
United States	The Cleveland Pediatric Research Center, LLC	Cleveland	Ohio
United States	Midsouth Center for Clinical Research	Memphis	Tennessee
United States	Institute of Clinical Research, LLC	Mentor	Ohio
United States	Springs Medical Research	Owensboro	Kentucky
United States	Watching Over Mothers and Babies	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Characteristics	Parent completed diary	Study Day 1 - Study Day 21
Secondary	Formula Intake	Parent completed diary	Study Day 1 - Study Day 21
Secondary	Weight	Scale	Study Day 1 - Study Day 21
Secondary	Length	Length board	Study Day 1 - Study Day 21