Probiotics in the prevention of atopy in infants and children
| ISRCTN | ISRCTN26287422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26287422 |
- Submission date
- 27/04/2005
- Registration date
- 15/06/2005
- Last edited
- 28/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Gareth Morgan
Scientific
Scientific
Clinical School
University of Wales
Singleton Park
Swansea
SA2 8PP
United Kingdom
| Phone | +44 (0)1792 513390 |
|---|---|
| gareth.morgan@swansea.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Scientific title | Probiotics in the prevention of atopy in infants and children (PROBAT) |
| Study 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(s) | Approved February 2004, South West Wales Research Ethics Committee (no address; no telephone number; no email address), ref: 2004024 |
| 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 | Supplement |
| Primary outcome measure | 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 study start date | 01/05/2005 |
| Overall study end date | 31/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 600 |
| Total final enrolment | 454 |
| 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 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 | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Clinical School
Swansea
SA2 8PP
United Kingdom
SA2 8PP
United Kingdom
Sponsor information
University of Wales, Swansea (UK)
University/education
University/education
Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom
"ROR" |
https://ror.org/053fq8t95 |
|---|
Funders
Funder type
Government
Knowledge exploitation fund, Collaborative Industrial Research Project number: HE 09 COL 1002, Welsh Assembly Government (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to terms and consideration of ethical and governance approvals. Data will be made available upon reasonable request to the project team. Detailed data are available in the supplementary material of https://www.ncbi.nlm.nih.gov/pubmed/29769554. At the time of writing, the researchers hold data for the 2- and 5-year follow up. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | No | No | |||
| Results article | 01/03/2010 | Yes | No | ||
| Results article | 01/11/2014 | Yes | No | ||
| Results article | 5-year extension results | 16/05/2018 | 24/10/2019 | Yes | No |
| Results article | 09/07/2013 | 28/06/2021 | Yes | No | |
| Other publications | Exploratory follow-up | 25/04/2025 | 28/05/2025 | Yes | No |
Editorial Notes
28/05/2025: Publication reference added.
15/07/2022: The ethics approval has been added.
07/07/2021: Total final enrolment and IPD sharing statement added.
06/07/2021: The recruitment end date was changed from 31/12/2011 to 31/12/2007.
28/06/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2011 to 31/07/2021.
2. Publication reference added.
24/10/2019: Publication reference added.
