Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01431469 |
Recruitment Status :
Completed
First Posted : September 9, 2011
Last Update Posted : December 6, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Infection Diarrheal Disease | Dietary Supplement: Cow's milk Dietary Supplement: Follow-On Formula | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Cow's Milk
Powdered Whole Cow's Milk
|
Dietary Supplement: Cow's milk
Powdered Whole Cow's Milk |
Experimental: Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
|
Dietary Supplement: Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide |
- Episodes of acute respiratory infections and diarrheal disease [ Time Frame: 28 weeks ]
- Occurrence of allergic manifestations [ Time Frame: 28 weeks ]
- Systemic antibiotic use [ Time Frame: 28 weeks ]
- Duration of acute respiratory infection and diarrheal disease [ Time Frame: 28 weeks ]
- Changes in stool patterns [ Time Frame: 28 weeks ]
- Fecal and serum immune markers [ Time Frame: 28 weeks ]
- Serum Ferritin and Zinc status [ Time Frame: 28 weeks ]
- Incidence of stool parasites [ Time Frame: 28 weeks ]
- Growth [ Time Frame: 28 weeks ]
- Incidence of adverse events [ Time Frame: 28 weeks ]The incidence of any adverse event for each participant
- Acceptance of study product [ Time Frame: 28 weeks ]Acceptance of study product based on quantity consumed

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Months to 48 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Child 12-48 months of age
- Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
- Signed informed consent
Exclusion Criteria:
- Child who is receiving predominantly breast-milk
- Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
- Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
- Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- Child's z-score of weight for length/height < -3 according to World Health Organization criteria

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): NCT01431469
Brazil | |
Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela | |
Salvador, Bahia, Brazil, CEP 401 10-060 |
Responsible Party: | Mead Johnson Nutrition |
ClinicalTrials.gov Identifier: | NCT01431469 |
Other Study ID Numbers: |
6001 |
First Posted: | September 9, 2011 Key Record Dates |
Last Update Posted: | December 6, 2012 |
Last Verified: | December 2012 |
Respiratory Tract Infections Diarrhea Infection Respiratory Tract Diseases Signs and Symptoms, Digestive |