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

NCT05215080 | Completed

• 1 other identifier: CRP/2021/XI/001/AFA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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, 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

Outcome Measures

Primary Outcomes (3)

• Participants with diarrhea defined by WHO definition of diarrhea

  Evaluate the acceptability of organic formula milk on infants by observing the stool consistency and frequency of passing stool

  12 weeks

• Participants with atopic dermatitis in Hanifin-Rajka criteria

  Evaluate any atopic dermatitis manifestation arise during organic formula milk consumption based on Hanifin Rajka Criteria

  12 Weeks

• Participants with food allergy measured by positive Oral Food Challenge

  Evaluate any allergic reaction during organic formula milk consumption based on positive oral food challenge

  12 Weeks

Secondary Outcomes (6)

• Diversity of gut microbiota in operational taxonomic unit

  12 weeks

• Abundance of gut microbiota in operational taxonomic unit

  12 weeks

• Concentration of gut short chain fatty acids in mMol

  12 weeks

• Body weight in kilograms measured with Krisbow electronic baby scale 10110689

  12 weeks

• Body length in centimeters measured with Krisbow electronic baby scale 10110689

  12 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

Group of infants aged 6-7 months that given organic formula milk 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.

Dietary Supplement: Organic Formula Milk

Interventions

Organic Formula Milk DIETARY_SUPPLEMENT

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.

Treatment group

Eligibility Criteria

• Age: 6 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 6-7 months of age.
• Gestational age 38-42 weeks
• Birth weight \>2700 and \<4200 gram
• Parents want to follow the study by signing the informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasanuddin University: lead
• Arla Foods: collaborator

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (4)

• Ohno H. Gut microbial short-chain fatty acids in host defense and immune regulation. Inflammation and regeneration. 2015;35:114-121

  BACKGROUND

• Inoue Y, Shimojo N. Microbiome/microbiota and allergies. Semin Immunopathol. 2015 Jan;37(1):57-64. doi: 10.1007/s00281-014-0453-5. Epub 2014 Oct 18.

  PMID: 25326106 BACKGROUND

• Sakurai K, Miyaso H, Eguchi A, Matsuno Y, Yamamoto M, Todaka E, Fukuoka H, Hata A, Mori C; Chiba study of Mother and Children's Health Group. Chiba study of Mother and Children's Health (C-MACH): cohort study with omics analyses. BMJ Open. 2016 Jan 29;6(1):e010531. doi: 10.1136/bmjopen-2015-010531.

  PMID: 26826157 BACKGROUND

• Simonyte Sjodin K, Vidman L, Ryden P, West CE. Emerging evidence of the role of gut microbiota in the development of allergic diseases. Curr Opin Allergy Clin Immunol. 2016 Aug;16(4):390-5. doi: 10.1097/ACI.0000000000000277.

  PMID: 27253486 BACKGROUND

Study Officials

• Bahrul Fikri, MD, PhD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Doctor of Philosophy, Principal Investigator

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 31, 2022
• Study Start: December 7, 2021
• Primary Completion: March 7, 2022
• Study Completion: May 31, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: The data will be shared by email sent by the primary investigator

Locations

ID (1)