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

Mead Johnson Nutrition

Status: Completed

Conditions: Acute Respiratory Infection; Diarrheal Disease

Treatments: Dietary Supplement: Follow-On Formula; Dietary Supplement: Cow's milk

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01431469

6001

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 12 to 48 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

Cow's Milk

Placebo Comparator group

Description:

Powdered Whole Cow's Milk

Treatment:

Dietary Supplement: Cow's milk

Follow-On Formula

Experimental group

Description:

Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

Treatment:

Dietary Supplement: Follow-On Formula