ACTRN12618001992291Withdrawn未知
Randomised placebo-controlled trial investigating the effect of 8 weeks supplementation with probiotics and vitamin D around routine childhood immunisation on infant's ear temperature, growth, and sleeping pattern in 4-24 month-old infants.
AProf Dr Karin Ried0 sites50 target enrollmentStarted: December 12, 2018Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Withdrawn
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 4 Months to 24 Months (—)
- Sex
- All
Inclusion Criteria
- •Group 1 (preferred): Infants who have not yet been immunised (age range: 4-24 months).
- •Group 2: Infants who have been immunised (age range: 4-24 months).
- •Parents have agreed to have their child immunised.
- •Normal infant growth as per WHO growth charts
- •No tympanic temperature > 38 degrees Celsius in the preceding 4 weeks prior to immunisation
- •Infants currently breastfed (e.g. exclusively or breast and formula fed)
- •Infants currently not taking supplements (Vitamin D and/or probiotics)
- •Infants who will remain in the same routine with primary carers for the 2 month study period
Exclusion Criteria
- •Infant has any severe allergies (particularly corn or maize products, as probiotics and placebo powder contains maltodextrin)
- •Infant has a disease that lowers their immunity (ie. leukaemia, cancer, HIV/AIDs)
- •Infant is having treatment that lowers immunity (ie. steroids, immunotherapy, chemotherapy)
- •Infant’s mother is receiving highly immunosuppressive therapy (ie. biological disease modifying anti-rheumatic drugs (bDMARDs)
- •Infant has had an immunoglobulin injection, received any blood products or blood transfusion)
- •Infant has had a past history of Guillain-Barre syndrome
- •Infant has a chronic illness
- •Infant has a bleeding disorder
- •Infant is ATSI (Aboriginal Torres Strait Islander)
- •Infant does not have functional spleen
- •Infant lives with someone who is immunocompromised (ie. leukaemia, cancer, HIV/AIDS, chemotherapy)
Investigators
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