Condition category
Skin and Connective Tissue Diseases
Date applied
25/03/2009
Date assigned
27/05/2009
Last edited
27/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Geun Eog Ji

ORCID ID

Contact details

San 56-1
Shinlimdong
Kwanakku
Seoul
152-742
Korea
South
geji@snu.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

Ethical Committee at the Samsung Medical Center gave approval on the 14th March 2005 (ref: 2005-03-033)

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Probiotics (Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus)

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

110

Participant exclusion criteria

1. Babies with a congenital disorder
2. Premature babies

Recruitment start date

01/01/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

Korea, South

Trial participating centre

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

Sponsor information

Organisation

Ministry for Health, Welfare and Family Affairs (South Korea)

Sponsor details

75
Yulgong-ro
Jongno-gu
Seoul
110-793
Korea
South
kchangu@khidi.or.kr

Sponsor type

Government

Website

http://english.mw.go.kr/front_eng/main.jsp

Funders

Funder type

Government

Funder name

Ministry for Health, Welfare and Family Affairs (South Korea) (grant ref: A060546 and A080664)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes