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Probiotic in Infant Growth, Allergy and Immunity Study | Clinical Trials | Clareo Health

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Probiotic in Infant Growth, Allergy and Immunity Study

Prospective, Placebo-Controlled, Randomized Double-Blind Clinical Study on the Intervention of Animal-Derived Probiotic in Infant Growth and Development, Allergy Incidence, and Immune Function

NCT06412042•Wecare Probiotics Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the intervention effects of Bifidobacterium animalis subsp. lactis strain BLa80 in promoting growth and development (including gut microbiota and physical growth and development) of healthy infants and young children across different age groups, enhancing immune function, improving allergy incidence, and analyzing the safety of BLa80 in relation to infant growth and development, allergy incidence, and gut microbiota.

Eligibility

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy infants and young children born at 37 to 42 weeks of gestation through both artificial breastfeeding, with a birth weight greater than or equal to 2500 g and less than 4000 g, regardless of gender
•2. Infants and young children whose mothers do not have diagnosed metabolic disorders such as diabetes and are not afflicted with communicable diseases such as hepatitis B or HIV
•3. Enrollment will be stratified into three age groups: 0-6 months, 6-12 months, and 12-36 months
•4. Consent from parents or primary caregivers of infants and young children to collect faecal samples during the study
•5. No clinically diagnosed allergic diseases at the time of enrolment (including but not limited to eczema, asthma, allergic colitis, allergic rhinitis, pollen allergies, etc.)
•6. Infants and young children with a medical record established at local maternal and child health care hospital's paediatrics department, undergoing regular check-ups, and following feeding advice and guidance from pediatricians
•7. Assurance from family members or primary caregivers not to administer additional probiotic products (including formula milk containing probiotics) to infants and young children during the intervention period.

Exclusion Criteria

•Healthy infants and young children aged 0-6 months:
•1. Infants with a history of asphyxia at birth or a history of NICU hospitalization
•2. Infants born with congenital defects or abnormalities
•3. Infants whose mother had pregnancy-related conditions such as gestational hypertension, pre-eclampsia or eclampsia, gestational diabetes, cholestasis of pregnancy, or other high-risk obstetric factors, as well as a history of alcohol or drug abuse during pregnancy
•4. Infants who have used antibiotics within 2 weeks prior to enrollment
•5. Infants who have had specific diseases affecting growth and development within 1 month prior to enrollment (e.g., pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.)
•6. Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
•7. Infants who have used investigational drugs or participated in other clinical studies before screening
•8. Infants who have consumed probiotic products within 1 month prior to enrollment (calculated from birth to enrollment for infants aged \<1 month)
•9. Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
+23 more criteria

Locations (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Jakarta 10430, Indonesia

Key Dates

Start Date

June 15, 2024

Primary Completion Date

September 15, 2024

Completion Date

September 25, 2024

Last Updated

May 14, 2024

Enrollment

ESTIMATED participants

Conditions

HealthyInfant ALL

Interventions

Probiotic BLa80

DIETARY_SUPPLEMENT

Placebo Maltodextrin

OTHER

Contacts

Vicky Achmad Ginanjar, bachelor

CONTACT

+62 21 7695513, 7515932 vicky.achmad@equilab-int.com

Natalina Soesilawati, Dr.

CONTACT

+62 21 88324366

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Probiotic in Infant Growth, Allergy and Immunity Study

Inclusion Criteria

Exclusion Criteria

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