Probiotic in Infant Growth, Allergy and Immunity Study

NCT06412042 | Not Yet Recruiting

• 1 other identifier: WK2024006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Infant ALL

Outcome Measures

Primary Outcomes (1)

• Changes in gut microbiota

  Collect patient fecal samples, test for 16S rRNA.

  84 days

Study Arms (3)

Probiotic BLa80

EXPERIMENTAL

Participants receive one sachet per day containing probiotic BLa80 and maltodextrin (Day 0 to Day 84).

Dietary Supplement: Probiotic BLa80

Maltodextrin

PLACEBO COMPARATOR

Participants receive one sachet per day containing maltodextrin only, serving as the placebo (Day 0 to Day 84).

Other: Placebo Maltodextrin

Blank

NO INTERVENTION

Participants in this arm will not receive any intervention or placebo.

Interventions

Probiotic BLa80 DIETARY_SUPPLEMENT

Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.

Probiotic BLa80

Placebo Maltodextrin OTHER

Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.

Maltodextrin

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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
• Enrollment will be stratified into three age groups: 0-6 months, 6-12 months, and 12-36 months
• Consent from parents or primary caregivers of infants and young children to collect faecal samples during the study
• No clinically diagnosed allergic diseases at the time of enrolment (including but not limited to eczema, asthma, allergic colitis, allergic rhinitis, pollen allergies, etc.)
• 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
• 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.

You may not qualify if:

• Healthy infants and young children aged 0-6 months:
• Infants with a history of asphyxia at birth or a history of NICU hospitalization
• Infants born with congenital defects or abnormalities
• 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
• Infants who have used antibiotics within 2 weeks prior to enrollment
• 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.)
• Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
• Infants who have used investigational drugs or participated in other clinical studies before screening
• Infants who have consumed probiotic products within 1 month prior to enrollment (calculated from birth to enrollment for infants aged \<1 month)
• Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
• Infants with known allergies to the ingredients of probiotic products
• Children who require hospitalization for treatment due to malnutrition
• Other reasons that researchers consider as unsuitable for participation in the clinical trial, such as those that could affect efficacy evaluation or individuals with poor compliance
• Infants and young children aged 6-12 months with good health
• Infants who have used antibiotics within 2 weeks prior to enrollment

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Jakarta 10430, 10430, Indonesia

Location

Study Officials

• Natalina Soesilawati, Dr.

  Karya Medika II Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicky Achmad Ginanjar, bachelor

CONTACT

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

Natalina Soesilawati, Dr.

CONTACT

+62 21 88324366

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 14, 2024
• Study Start: June 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 25, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

ID (1)