Status:
UNKNOWN
Ingestion Effect of Formula Milk With Triple Bifidobacteria Strains on Fecal Quality and Metabolites in Healthy Children
Lead Sponsor:
Gadjah Mada University
Collaborating Sponsors:
PT Kalbe Farma Tbk
Morinaga Milk Industry Co., LTD
Conditions:
Children, Only
Eligibility:
All Genders
12-36 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to compare healthy children between 1 to 3 years old. The main question it aims to answer is 1. Is there an effect towards fecal quality after consuming milk formul...
Detailed Description
This clinical trial is a study of 3 strains of Bifidobacterium was conducted in infants aged 1-3 years in Indonesia. The general objective of this study was to determine the benefits of combined suppl...
Eligibility Criteria
Inclusion
- Age between 12 - 36 months
- Normal nutritional status (z-score height-for-age or z-score weight-for-height: -2 SD \< X \< 2 SD)
- Has no dairy allergies
- Does not consume breastmilk anymore during the intervention period
- Willing to participate through the whole research period
- Obtain consent from parents or guardians by signing the informed consent form
Exclusion
- Has a history of lactose intolerance, congenital and chronic diseases including irritable bowel syndrome, etc.
- Receive antibiotic or other probiotic supplementation during the 14 day of baseline period.
Key Trial Info
Start Date :
May 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT06044376
Start Date
May 2 2023
End Date
March 31 2024
Last Update
September 21 2023
Active Locations (10)
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1
PAUD Hiber Rotowijayan
Yogyakarta, Special Region of Yogyakarta, Indonesia, 55132
2
Paud Kunir Ceria Tegalgendu Kotagede
Yogyakarta, Special Region of Yogyakarta, Indonesia, 55172
3
Puskesmas Mlati 2
Yogyakarta, Indonesia, 55286
4
Paud Bodeh
Yogyakarta, Indonesia, 55294