The Tolerance of Organic Formula Milk and Its Fecal Microbiome Characteristic in Infants
Condition: Food Allergy in Infants
MeSH terms: Food Hypersensitivity
Study type: Interventional

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.
    

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's diet, any sign of colic on subjects, quality of sleep, and wellbeing. All
      the participants will be fed organic formula milk as a part of their dietary for 12 weeks.
      Before feeding the formula, the nutritional status will be measured and the participant's
      fecal will be collected for microbiome and short chain fatty acid (SCFA) examination. Every
      month the parents will be called in order to assess for child's sickness, allergy, body
      weight, length, head circumference, and to review their journal.

      A visit follow up will be done before and after the study, the tolerance, nutritional status
      (including body mass index) and fecal collection for all subjects will be performed. The
      investigators will also collect the allergy related data. Each fecal examination will follow
      a strict cold chain procedure, each sample will be collected directly, bottled, and frozen to
      minimize error. The frozen samples will be transported in insulated bags with frozen ice
      blocks before being transferred to -80°C for storage.

      A statistical analysis will be performed using r program and STATA 13.0. The Normality of
      data distribution will be tested using the Shapiro-Wilk test. To evaluate potential
      associations between factors in relation to fecal microbiome or SCFAs, Spearman's rank
      correlations will be calculated. A p-value <0.05 will be considered significant.

      The model will be adjusted for potential confounders. Estimated associations will be
      described as odds ratios (ORs) with 95% confidence intervals (CIs). The non-parametric
      Wilcoxon test for paired samples will be used to compare different laboratory parameters at
      different times of collecting samples. The Mann-Whitney U test for unpaired samples will be
      applied to compare different categorical parameter between infants before and after
      treatment. Multivariable linear regressions will be done to find out the association of
      different parameters change before and after treatment.
    

Intervention name(s): Organic Formula Milk
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention