Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil

• ClinicalTrials.gov Identifier: NCT01431469
• Recruitment Status: Completed
• First Posted: September 9, 2011
• Last Update Posted: December 6, 2012
• Sponsor: Mead Johnson Nutrition
• Collaborator: Federal University of Bahia
• Information provided by (Responsible Party): Mead Johnson Nutrition

Study Description

Brief Summary:

The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.

Condition or disease	Intervention/treatment	Phase
Acute Respiratory Infection; Diarrheal Disease	Dietary Supplement: Cow's milk; Dietary Supplement: Follow-On Formula	Not Applicable

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Episodes of acute respiratory infections and diarrheal disease [ Time Frame: 28 weeks ]

Secondary Outcome Measures :

1. Occurrence of allergic manifestations [ Time Frame: 28 weeks ]
2. Systemic antibiotic use [ Time Frame: 28 weeks ]
3. Duration of acute respiratory infection and diarrheal disease [ Time Frame: 28 weeks ]
4. Changes in stool patterns [ Time Frame: 28 weeks ]
5. Fecal and serum immune markers [ Time Frame: 28 weeks ]
6. Serum Ferritin and Zinc status [ Time Frame: 28 weeks ]
7. Incidence of stool parasites [ Time Frame: 28 weeks ]
8. Growth [ Time Frame: 28 weeks ]
9. Incidence of adverse events [ Time Frame: 28 weeks ]
   The incidence of any adverse event for each participant
10. Acceptance of study product [ Time Frame: 28 weeks ]
    Acceptance of study product based on quantity consumed

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 48 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Mead Johnson Nutrition

Federal University of Bahia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0.

• Responsible Party: Mead Johnson Nutrition
• ClinicalTrials.gov Identifier: NCT01431469
• Other Study ID Numbers: 6001
• First Posted: September 9, 2011
• Last Update Posted: December 6, 2012
• Last Verified: December 2012

Additional relevant MeSH terms:

Respiratory Tract Infections; Diarrhea; Infection; Respiratory Tract Diseases; Signs and Symptoms, Digestive