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New treatment option for Healthy Children
Official title To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
ClinicalTrials.gov ID: NCT07490587
What this study is testing
- What it's testing
- This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 36. Healthy volunteers may be eligible.
You may be able to join if
- Term infants are 37≤ gestational age \< 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0\~12 months old)
- Breastfed or mixed-fed healthy infants and young children, aged 0\~3 (inclusive) years old, gender is not limited
- The allergy risk score calculated by the Infant Allergy Risk Assessment Table is ≥6(Refer to the National Center for Women and Children's Health...
- Family primary guardians agree to collect fecal samples of infants and young children during this study
- Have not used antibiotics in the past month
You likely can't join if
- The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases
- Clinicians diagnosed with allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.)...
- Infants and young children who are known to be allergic to the ingredients of probiotic products
- In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study
See the full eligibility criteria
- Term infants are 37≤ gestational age \< 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0\~12 months old)
- Breastfed or mixed-fed healthy infants and young children, aged 0\~3 (inclusive) years old, gender is not limited
- The allergy risk score calculated by the Infant Allergy Risk Assessment Table is ≥6(Refer to the National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention: Investigation and...
- Family primary guardians agree to collect fecal samples of infants and young children during this study
- Have not used antibiotics in the past month
- Have not used probiotics in the past three months
- Family primary guardians committed not to add additional Bifidobacterium dietary supplements to infants and young children during the intervention period
- The guardians of the enrolled people agree to participate in this treatment study and sign a written informed consent form, and are able to understand and fill in forms such as infant diaries as required
- Signed informed consent and willing to follow up at the time specified in the trial
- The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases
- Clinicians diagnosed with allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at the time of enrollment of infants and young children
- Infants and young children who are known to be allergic to the ingredients of probiotic products
- In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Pudong, Shanghai Municipality, China
- Pulau Pinang, Pulau Pinang, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 months to 36 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pudong, Shanghai Municipality, China; Pulau Pinang, Pulau Pinang, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.