The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics

Metabolomics Clinical Trial

Official title:

The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02948114
• Other study ID #: 6026
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: April 2017

Study information

• Verified date: August 2018
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Singleton, 10-14 days of age at registration/randomization

• Term infant with birth weight of 2500 grams or more from a vaginal birth

• Formula feeding infants must be on formula for at least 3 days

• Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study

• Signed informed consent

Exclusion Criteria:

• History of underlying metabolic or chronic disease or immune compromised

• Feeding difficulties or formula intolerance

Related Conditions & MeSH terms

• Metabolomics

Intervention

Other:
• Control: Cow milk-based infant formula

• Experimental 1: Cow milk-based infant formula
Experimental 1: Cow milk-based infant formula with prebiotics
• Experimental 2: Cow milk-based infant formula
Experimental 2: Cow milk-based infant formula with probiotics
• Experimental 3: Cow milk-based infant formula
Experimental 3: Cow milk-based infant formula with prebiotics and probiotics

Locations

Country	Name	City	State
China	Hainan Province Women & Children Hospital	Haikou	Hainan

Sponsors (2)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Beijing Kangchen Technologies

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fecal microbiota		3.5 months
Secondary	Body Weight measured at each study visit		Up to 3.5 months
Secondary	Body Length measured at each study visit		Up to 3.5 months
Secondary	Head circumference measured at each study visit		Up to 3.5 months
Secondary	Recall of infant formula usage at each study visit		Up to 3.5 months
Secondary	Recall of gastrointestinal tolerance questionnaire at each study visit		Up to 3.5 months
Secondary	Medically-confirmed adverse events collected throughout the study period		Up to 3.5 months