Condition category
Signs and Symptoms
Date applied
27/04/2005
Date assigned
15/06/2005
Last edited
30/06/2014
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 Gareth Morgan

ORCID ID

Contact details

Clinical School
University of Wales
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 513390
gareth.morgan@swansea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PROBAT

Study hypothesis

Administration of probiotic organisms will reduce the incidence of atopy in infants and children and favourably influence key immune parameters associated with atopy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Atopy in infants and children

Intervention

Active intervention: probiotic supplement consisting of a combination of 4 strains of live bacteria (Lactobacillus salivarius LS33 6.25 x 10^9 cfu [Colony Forming Units], Lactobacillus paracasei CUL08 1.25 x 10^9 cfu, Bifidobacterium infantis Bi07 1.25 x 10^9 cfu and Bifidobacterium bifidum CUL20 1.25 x 10^9 cfu), as 100 mg freeze dried powder.

Placebo: maltodextrin 100 mg.

Mother takes the trial preparation daily with food, from 36 weeks gestation until delivery. After delivery, the preparation is administered to the baby daily from birth to age six months, either with feeds or directly into the mouth.

Intervention type

Drug

Phase

Not Specified

Drug names

Probiotics

Primary outcome measures

1. The presence of eczema during infancy (assessed by the SCORAD system)
2. The presence of asthma in children in the first five years
3. Changes in key immunological parameters associated with atopy

Secondary outcome measures

1. Compliance with/adherence to trial intervention
2. Adverse events

Overall trial start date

01/05/2005

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

600 women and their newborn infants recruited from the antenatal department of a maternity unit of a district general hospital, with informed written consent. Infants have a first degree relative with an atopic disorder.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

600

Participant exclusion criteria

1. Mother aged less than 16 years
2. Multiple pregnancy
3. Gestation at delivery less than 36 weeks
4. Parents unable or unwilling to give informed consent
5. Any adverse medical condition affecting the pregnancy or its likely outcome (e.g. known abnormality in foetus)
6. Member of sibship or household already recruited to the study

Recruitment start date

01/05/2005

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical School
Swansea
SA2 8PP
United Kingdom

Sponsor information

Organisation

University of Wales, Swansea (UK)

Sponsor details

Singleton Park
Swansea
SA2 8PP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Knowledge exploitation fund, Collaborative Industrial Research Project number: HE 09 COL 1002, Welsh Assembly Government (UK)

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

1. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20089774
2. 2012 results in: Allen SJ, Jordan S, Storey M, Thornton C, Gravenor M, et al.. (2012) Probiotics and atopic eczema: A double-blind randomised controlled trial. Arch Dis Child 97 S1 A2 P05. doi:10.1136/archdischild-2012-301885.5.
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24947281

Publication citations

  1. Results

    Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor M, Garaiova I, Plummer SF, Wang D, Morgan G, Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy., J. Nutr., 2010, 140, 3, 483-488, doi: 10.3945/jn.109.117093.

  2. Results

    Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor MB, Garaiova I, Plummer SF, Wang D, Morgan G, Probiotics in the prevention of eczema: a randomised controlled trial., Arch. Dis. Child., 2014, doi: 10.1136/archdischild-2013-305799.

Additional files

Editorial Notes