Status:

COMPLETED

The Tolerance of Organic Formula Milk and Its Fecal Microbiome Characteristic in Infants

Lead Sponsor:

Hasanuddin University

Collaborating Sponsors:

Arla Foods

Conditions:

Food Allergy in Infants

Eligibility:

All Genders

6-7 years

Phase:

NA

Brief Summary

This interventional study aims to investigate the tolerance of organic formula milk on infants supplemented with organic formula milk. This study also observes gut microbiota, short chain fatty acids,...

Detailed Description

All the guardians or parents of the participants in this study will be interviewed in order to record the dietary and sign for inform consent. Parents will be given a journal to record the participant...

Eligibility Criteria

Inclusion

  • Healthy infants 6-7 months of age.
  • Gestational age 38-42 weeks
  • Birth weight \>2700 and \<4200 gram
  • Not suffering from a major congenital anomaly, severely stunted at birth, not having a thyroid problem, not suffered from prominent gastrointestinal diseases, severe diseases at the time of inclusion (severe pneumonia, severe dehydration, etc)
  • Parents want to follow the study by signing the informed consent

Exclusion

  • Subjects are in the severe disease condition at the time of recruitment
  • Severe acute malnutrition
  • Have conditions that will influence the nutritional status such as moderate to severe dehydration, organomegaly, edema.

Key Trial Info

Start Date :

December 7 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2022

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT05215080

Start Date

December 7 2021

End Date

May 31 2022

Last Update

July 13 2022

Active Locations (1)

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Hasanuddin University

Makassar, South Sulawesi, Indonesia, 90245