Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000374268
Ethics application status
Approved
Date submitted
11/05/2009
Date registered
27/05/2009
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The safety and efficacy of a locally available probiotic in premature infants.
Scientific title
A randomised placebo controlled pilot trial on the safety and efficacy of a probiotic product in reducing all case mortality and definite necrotizing enterocolitis in preterm very low birthweight neonates.
Secondary ID [1] 282140 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PANTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Necrotising Enterocolitis 4756 0
all cause mortality and time to full feeds in preterm very low birthweight neonates 4868 0
Condition category
Condition code
Reproductive Health and Childbirth 237093 237093 0 0
Complications of newborn
Oral and Gastrointestinal 237094 237094 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective double blind placebo controlled randomised trial investigating the safety and efficacy of a locally available probiotic product.
Enrolled neonates will be allocated to the product (containing Lactobacillus acidophilus 375 million, Bifidobacterium bifidum & Bifidobacterium longus 125 million organisms) or an identical looking placebo containing maltodextrin.
This is available in tablet form, which is crushed and mixed with 3ml of sterile water at the bedside, and given twice daily by mouth / gastric tube, from the start of enteral feeds until discharged home or term (37 weeks post menstral age) whichever comes first.
Intervention code [1] 4531 0
Prevention
Comparator / control treatment
The placebo will appear identical to the probiotic and consist of maltodextrin.
Control group
Placebo

Outcomes
Primary outcome [1] 5925 0
Gut colonisation by probiotic bacteria assessed by quantitative stool culture
Timepoint [1] 5925 0
one sample collected before commencing supplement and then another sample colleced after four weeks of supplement (probiotic or placebo)
Secondary outcome [1] 242014 0
All cause mortality
Timepoint [1] 242014 0
During first admission after birth
Secondary outcome [2] 242015 0
Stage II Necrotising Enterocolitis (NEC) or greater (Bell Staging)
Timepoint [2] 242015 0
At death or discharge
Secondary outcome [3] 242016 0
Late onset sepsis (blood culture positive after 72 hrs of life)
Timepoint [3] 242016 0
At death or discharge
Secondary outcome [4] 242017 0
Time to reach full feeds (150 ml/kg/day)
Timepoint [4] 242017 0
At death or discharge

Eligibility
Key inclusion criteria
(1)Gestation up to 32 weeks and 6 days
(2)Birth weight under 1500 grams
(3)Ready to commence or on enteral feeds for up to 12 hours
(4) Parental Consent
Minimum age
No limit
Maximum age
32 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Major congenital malformation
(2) Chromosomal aberration
(3) Lack of informed parental consent
(4) On enteral feeds for more than 12 hours
(5) Contraindications for enteral feds
(6) Life threatening illness/condition

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After obtaining informed parental consent, babies will be allocated to study supplement (product or placebo) from computer generated random numbers concealed in sealed, coded opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be by computer generated random numbers.
Randomisation will be stratified by gestation up to 27weeks + 6days and above 28weeks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2009
Actual
7/12/2010
Date of last participant enrolment
Anticipated
Actual
21/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4941 0
Charities/Societies/Foundations
Name [1] 4941 0
Telethon
Country [1] 4941 0
Australia
Primary sponsor type
Hospital
Name
Womens and Childrens Health Service
Address
King Edward Memorial Hospital
374 Bagot Rd
Subiaco
Perth WA 6008
Country
Australia
Secondary sponsor category [1] 4462 0
Individual
Name [1] 4462 0
A/Prof Sanjay Patole
Address [1] 4462 0
Neonatal Paediatrics
King Edward Memorial Hospital
374 Bagot Rd
Subiaco
Perth WA 6008
Country [1] 4462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7042 0
King Edward Memorial Hospital Committee
Ethics committee address [1] 7042 0
King Edward Memorial Hospital
374 Bagot Rd
Subiaco
Perth WA 6008
Ethics committee country [1] 7042 0
Australia
Date submitted for ethics approval [1] 7042 0
Approval date [1] 7042 0
07/04/2009
Ethics approval number [1] 7042 0
1649/EW

Summary
Brief summary
This is a two stage project:
(1) independent microbiological studies to confirm the identity of the probiotic bacteria and the safety (contaminants, unspecified contents, osmolarity) of the probiotic product followed by
(2) a pilot clinical trial to test the hypothesis that routine supplementation with this probiotic product will result in colonisation of the gut (primary hypothesis) and reduction in all cause deaths, and diseases like NEC, and late onset sepsis (secondary hypotheses) in premature babies.
Trial website
Trial related presentations / publications
Patole S, Keil AD, Chang A, Nathan E, Doherty D, Simmer K, Esvaran M, Conway
P. Effect of Bifidobacterium breve M-16V supplementation on fecal bifidobacteria
in preterm neonates--a randomised double blind placebo controlled trial. PLoS
One. 2014 Mar 3;9(3):e89511. doi: 10.1371/journal.pone.0089511. eCollection 2014.
PubMed PMID: 24594833; PubMed Central PMCID: PMC3940439.
Public notes

Contacts
Principal investigator
Name 29591 0
Prof Patole Sanjay
Address 29591 0
Department of neonatal paediatrics, KEM Hospital for Women, 374 Bagot Road, Subiaco, Perth, western Australia 6008
Country 29591 0
Australia
Phone 29591 0
61-8-93401260
Fax 29591 0
Email 29591 0
sanjay.patole@health.wa.gov.au
Contact person for public queries
Name 12838 0
Prof Sanjay Patole
Address 12838 0
Neonatal Paediatrics
King Edward Memorial Hospital
374 Bagot Rd
Subiaco
Perth WA 6008
Country 12838 0
Australia
Phone 12838 0
+61 8 9340 1260
Fax 12838 0
Email 12838 0
sanjay.patole@health.wa.gov.au
Contact person for scientific queries
Name 3766 0
Prof Sanjay Patole
Address 3766 0
Neonatal Paediatrics
King Edward Memorial Hospital
374 Bagot Rd
Subiaco
Perth WA 6008
Country 3766 0
Australia
Phone 3766 0
+61 8 9340 1260
Fax 3766 0
Email 3766 0
sanjay.patole@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Bifidobacterium breve M-16V supplementation on fecal bifidobacteria in preterm neonates - A randomised double blind placebo controlled trial.2014https://dx.doi.org/10.1371/journal.pone.0089511
N.B. These documents automatically identified may not have been verified by the study sponsor.