Effect of probiotics in the primary prevention of atopic eczema

ISRCTN	ISRCTN26134979
DOI	https://doi.org/10.1186/ISRCTN26134979
Protocol serial number	N/A
Sponsor	Ministry for Health, Welfare and Family Affairs (South Korea)
Funder	Ministry for Health, Welfare and Family Affairs (South Korea) (grant ref: A060546 and A080664)

Submission date: 25/03/2009
Registration date: 27/05/2009
Last edited: 10/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Geun Eog Ji
Scientific

San 56-1, Shinlimdong
Kwanakku
Seoul
152-742
Korea, South

Email	geji@snu.ac.kr

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effect of probiotics (Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus) in the primary prevention of atopic dermatitis: a double-blind, randomised, placebo-controlled trial
Study objectives	To investigate whether prenatal and postnatal administration of a mixture of Bifidobacteria and Lactobacillus can prevent the development of atopic dermatitis (AD) and sensitisation against common food allergens in infants at high risk of atopic disease.
Ethics approval(s)	Ethical Committee at the Samsung Medical Center gave approval on the 14th March 2005 (ref: 2005-03-033)
Health condition(s) or problem(s) studied	Atopic eczema
Intervention	The selected participants were assigned to treatment groups by computerised block-randomisation and received either probiotics or placebo. Mothers in the probiotics group took a mixture of Bifidobacterium bifidum BGN4 (1.6 x 10^9 colony forming units [CFU]), Bifidobacterium lactis AD011 (1.6 x 10^9 CFU) and Lactobacillus acidophilus AD031 (1.6 x 10^9 CFU) in 0.72 g of maltodextrin and 0.8 g of alpha-corn (Bifido Inc., Hongchungun, Korea) once daily from 4 weeks before delivery to 3 months after delivery. Infants were fed the same powder dissolved in breast milk, infant formula, or sterile water from 4 to 6 months of age. Mothers and infants in the placebo group took maltodextrin and alpha-corn without probiotic bacteria. All mothers were requested to breastfeed their infants for at least 3 months after birth. Thereafter, they were permitted to feed their infants with cow's milk formula. Lactating mothers and infants were prevented from eating peanuts and eggs, as well as yogurt and other probiotic functional foods, during the course of the study.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Probiotics (Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus)
Primary outcome measure(s)	1. Rate of caesarean delivery, collected at 3 months of infant's age 2. Total duration of the breastfeeding, collected at 3, 6, and 12 months of infant's age 3. Infections, collected at 3, 6, and 12 months of infant's age 4. Antibiotic use, collected at 3, 6, and 12 months of infant's age 5. Hospitalisation during infancy, collected at 3, 6, and 12 months of infant's age 6. Prevalence of respiratory infection and acute gastroenteritis, collected at 3, 6, and 12 months of infant's age 7. Frequency of fever above 38.5°C, collected at 3, 6, and 12 months of infant's age 8. Serious adverse events related to the administration of probiotics, collected at 3, 6, and 12 months of infant's age
Key secondary outcome measure(s)	1. Effects of probiotics on development of atopic dermatitis, collected at 3, 6, and 12 months of infant's age 2. Severity of AD, assessed by the Six Area Six Sign Atopic Dermatitis (SASSAD) scoring system, collected at 3, 6, and 12 months of infant's age 3. IgE sensitisation, measured at 1 year of infants' age
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	110
Total final enrolment	112
Key inclusion criteria	Pregnant adult women with a family history of atopic diseases. A positive family history was defined as the presence of at least one first-degree family member having AD, asthma, or allergic rhinitis. The AD of members of the participants' families was confirmed by a physician at enrolment. Those who had been diagnosed as having asthma or allergic rhinitis were selected only when they showed house dust mite-specific immunoglobulin E (IgE) over 1.0 kU/l by cap-system fluorescent enzyme immunoassay (CAP-FEIA) (Pharmacia, Uppsala, Sweden).
Key exclusion criteria	1. Babies with a congenital disorder 2. Premature babies
Date of first enrolment	01/01/2005
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

Korea, South

Study participating centre

San 56-1, Shinlimdong

Seoul
152-742
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2010	10/07/2019	Yes	No

Editorial Notes

10/07/2019: Publication reference and total final enrolment added.