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

NCT05215080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-13

No results posted yet for this study

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, nutritional status, and atopic manifestation on infants supplemented with organic formula milk. This study will be done on 50 subjects, with an age of 6-7 months old, 38-42 weeks of gestation, had a birth weight ranging from 2700 grams to 4200 grams, not suffering from any major congenital anomaly, not severely stunted at birth, has a normal thyroid function, not suffering any prominent gastrointestinal disease, not having a severe disease at the beginning of study, and has an approval from their parents. Participants' diet will be added an organic formula for infant for 3 months, and will be monitored regularly, since this study starts, at each month, and at the end of this study. The participants' gut microbiomes will be calculated at every session of monitoring by collecting their fecal samples, and brought to laboratory. Anthropological data (weight, height, body mass index), atopic manifestation, IL-6 and IL-10 will also be collected.

Conditions

  • Food Allergy in Infants

Interventions

DIETARY_SUPPLEMENT

Organic Formula Milk

Organic formula milk is given to the infants three times a day for three months. Each serving contains 7 spoons (1 spoon contain 4,6 grams) of milk powder and 210 ml of water.

Sponsors & Collaborators

  • Arla Foods

    collaborator INDUSTRY

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Bahrul Fikri, MD, PhD · Hasanuddin University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-03-07
Completion
2022-05-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215080 on ClinicalTrials.gov