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OpenTrials
Completed

NCT Number: NCT01431469

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

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

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Key information

Conditions

Acute Respiratory Infection Diarrheal Disease

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, Estado de Bahia, CEP 401 10-060, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cow's milk

Dietary Supplement

Powdered Whole Cow's Milk

Follow-On Formula

Dietary Supplement

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

Primary outcomes

  1. Episodes of acute respiratory infections and diarrheal disease

    Time frame: 28 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • Federal University of Bahia

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2011
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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