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

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ClinicalTrials.gov Identifier: NCT02948114
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
Beijing Kangchen Technologies
Information provided by (Responsible Party):
Mead Johnson Nutrition

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolomics Other: Control: Cow milk-based infant formula Other: Experimental 1: Cow milk-based infant formula Other: Experimental 2: Cow milk-based infant formula Other: Experimental 3: Cow milk-based infant formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
Study Start Date : October 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control: Cow milk-based infant formula
Cow milk-based infant formula
Other: Control: Cow milk-based infant formula
Experimental: Experimental 1: Cow milk-based infant formula
Cow milk-based infant formula with prebiotics
Other: Experimental 1: Cow milk-based infant formula
Experimental 1: Cow milk-based infant formula with prebiotics

Experimental: Experimental 2: Cow milk-based infant formula
Cow milk-based infant formula with probiotics
Other: Experimental 2: Cow milk-based infant formula
Experimental 2: Cow milk-based infant formula with probiotics

Experimental: Experimental 3: Cow milk-based infant formula
Cow milk-based infant formula with prebiotics and probiotics
Other: Experimental 3: Cow milk-based infant formula
Experimental 3: Cow milk-based infant formula with prebiotics and probiotics

No Intervention: Human Milk Reference
Human Milk Reference



Primary Outcome Measures :
  1. Change in fecal microbiota [ Time Frame: 3.5 months ]

Secondary Outcome Measures :
  1. Body Weight measured at each study visit [ Time Frame: Up to 3.5 months ]
  2. Body Length measured at each study visit [ Time Frame: Up to 3.5 months ]
  3. Head circumference measured at each study visit [ Time Frame: Up to 3.5 months ]
  4. Recall of infant formula usage at each study visit [ Time Frame: Up to 3.5 months ]
  5. Recall of gastrointestinal tolerance questionnaire at each study visit [ Time Frame: Up to 3.5 months ]
  6. Medically-confirmed adverse events collected throughout the study period [ Time Frame: Up to 3.5 months ]


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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948114


Contacts
Contact: Steven Wu steven.wu@mjn.com

Locations
China, Hainan
Hainan Province Women & Children Hospital Recruiting
Haikou, Hainan, China
Principal Investigator: Wei Xiang, PhD         
Sponsors and Collaborators
Mead Johnson Nutrition
Beijing Kangchen Technologies
Investigators
Study Director: Steven Wu Mead Johnson Nutrition

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT02948114     History of Changes
Other Study ID Numbers: 6026
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017