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Trial registered on ANZCTR


Registration number
ACTRN12611001208998
Ethics application status
Approved
Date submitted
21/11/2011
Date registered
23/11/2011
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotics for the prevention of gestational diabetes in overweight and obese women.
Scientific title
Randomized placebo controlled trial of probiotics in overweight and obese women to assess the prevention of gestational diabetes
Secondary ID [1] 273421 0
Nil
Secondary ID [2] 287667 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPRING
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 279210 0
overweight/obesity 279222 0
Condition category
Condition code
Metabolic and Endocrine 279416 279416 0 0
Diabetes
Diet and Nutrition 279429 279429 0 0
Obesity
Reproductive Health and Childbirth 279430 279430 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of lactobacillus rhamnosus GG and bifidobacterium lactis BB12 capsules with at least 7 billion organisms once daily. Treatment starts at 16 weeks gestation and is continued until delivery.
Intervention code [1] 283757 0
Treatment: Other
Intervention code [2] 283767 0
Prevention
Comparator / control treatment
Matched placebo
Control group
Placebo

Outcomes
Primary outcome [1] 285986 0
gestational diabetes on oral glucose tolerance test at 28 weeks gestation.
Timepoint [1] 285986 0
28 weeks gestation
Secondary outcome [1] 294899 0
Maternal weight gain from enrolment to 36 weeks gestation
Timepoint [1] 294899 0
36 weeks gestation
Secondary outcome [2] 294900 0
Preeclampsia as diagnosed by the criteria of the International Society for the Study of Hypertension in Pregnancy (ISSHP) and described in the patient antenatal care records.
Timepoint [2] 294900 0
delivery
Secondary outcome [3] 294901 0
Induction of labour as described in the patient records.
Timepoint [3] 294901 0
delivery
Secondary outcome [4] 294922 0
Delivery by Caesarean section as described in the patient records.
Timepoint [4] 294922 0
delivery
Secondary outcome [5] 294923 0
Change in stool flora measured by PCR analysis of the stool samples and compared to the baseline sample prior to 16 weeks gestation.
Timepoint [5] 294923 0
At 28 weeks gestation
Secondary outcome [6] 294924 0
Change in serum maternal lipids e.g. FFA, TGs, HDL and LDL cholesterol as measured by ELISA and RIA and compared to the baseline sample prior to 16 weeks gestation.
Timepoint [6] 294924 0
At 28 weeks gestation and after delivery
Secondary outcome [7] 294925 0
Change in serum inflammatory markers, e.g. an array of cytokines en chemokines measured by ELISA/bioluminescence and compared to the baseline sample prior to 16 weeks gestation.
Timepoint [7] 294925 0
At 28 weeks gestation and after delivery
Secondary outcome [8] 294926 0
Change in diet or exercise as measured by the Diet quality (Fat Fibre Index as developed by The University of Queensland) and Pregnancy Physical Activity Questionnaire and compared to the baseline data recorded prior to 16 weeks gestation.
Timepoint [8] 294926 0
At 28 weeks gestation
Secondary outcome [9] 294927 0
Compliance with capsule intake as measured by capsule counting on monthly review visits.
Timepoint [9] 294927 0
At 20, 24, 28, 32, 36 weeks gestation
Secondary outcome [10] 294928 0
Infant body composition as measured by air displacement plethysmography (PeaPOD) which gives a proportional measure of total infant body fat.
Timepoint [10] 294928 0
Within 1 week after delivery
Secondary outcome [11] 294929 0
Premature delivery as described in the maternal records of delivery
Timepoint [11] 294929 0
At delivery
Secondary outcome [12] 294930 0
Infant shoulder dystocia as recorded in infant's birth records.
Timepoint [12] 294930 0
At delivery
Secondary outcome [13] 294931 0
Infant anthropometry as recorded in baby's birth records.
Timepoint [13] 294931 0
At delivery
Secondary outcome [14] 294932 0
Infant bone fractures as recorded in infant's birth records.
Timepoint [14] 294932 0
At delivery
Secondary outcome [15] 294933 0
Nerve palsy as recorded in infant's neonatal records.
Timepoint [15] 294933 0
Within 1 week of delivery
Secondary outcome [16] 294934 0
Infant admission to the neonatal intensive care unit or special care nursery as recorded in the neonatal records.
Timepoint [16] 294934 0
Within 1 month of delivery
Secondary outcome [17] 294935 0
Infant requirement for supplementary feeding or fluids to treat hypoglycaemia as recorded in the neonatal records.
Timepoint [17] 294935 0
Within 1 week of delivery
Secondary outcome [18] 294936 0
Infant jaundice requiring phototherapy as recorden in the neonatal records.
Timepoint [18] 294936 0
Within 1 week of delivery
Secondary outcome [19] 294937 0
Stillbirth as recorded in the delivery records.
Timepoint [19] 294937 0
At delivery
Secondary outcome [20] 294938 0
Neonatal death as recorded in the neonatal records.
Timepoint [20] 294938 0
Within 1 month of delivery.

Eligibility
Key inclusion criteria
BMI greater than 25
Can read and understand English
Less than 16 weeks pregnant
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Gestation >16 weeks
Pre-existing type 1 or type 2 diabetes
Pre-existing impaired fasting glucose or impaired glucose tolerance
GDM on early screening
Medications likely to influence glucose metabolism (eg metformin, glucocorticoids, immunosuppressants)
Medical conditions associated with altered glucose metabolism -eg Cushings, cirrhosis of the liver
Known fetal abnormality on the 12-13 week ultrasound scan
Known ingestion of probiotics via capsule

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)
Placebo and probiotics will be identically packaged and refrigerated. All doctors, research assistants, nursing staff and participants will be masked to the randomised allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be managed by the Royal Brisbane and Womens' Hospital Pharmacy, using a telephone based protocol as employed in other studies, based on random number codes. Participants will be stratified by study centre and by BMI category (BMI >25-30, BMI >30-40, BMI>40)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 4455 0
Redcliffe Hospital - Redcliffe

Funding & Sponsors
Funding source category [1] 284233 0
Government body
Name [1] 284233 0
National Health and Medical Research Council
Address [1] 284233 0
GPO Box 1421
Canberra ACT 2601
Country [1] 284233 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 269189 0
Hospital
Name [1] 269189 0
Mater Mothers Hospital, Brisbane
Address [1] 269189 0
Raymond Terrace
South Brisbane, Qld 4101
Country [1] 269189 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286196 0
Royal Brisbane and Women's Hospital Health Research Ethics Committee
Ethics committee address [1] 286196 0
Butterfield St
Herston QLD 4029
Ethics committee country [1] 286196 0
Australia
Date submitted for ethics approval [1] 286196 0
21/11/2011
Approval date [1] 286196 0
16/01/2012
Ethics approval number [1] 286196 0
Ethics committee name [2] 286211 0
Mater Hospital Health Research Ethics Committee
Ethics committee address [2] 286211 0
Raymond Terrace
South Brisbane, Qld. 4101
Ethics committee country [2] 286211 0
Australia
Date submitted for ethics approval [2] 286211 0
01/02/2012
Approval date [2] 286211 0
21/02/2012
Ethics approval number [2] 286211 0

Summary
Brief summary
With the rise in overweight and obesity, the number of women developing diabetes in pregnancy increases as well. Diabetes in pregnancy is associated with complications for mother and baby during the pregnancy but also later in life with higher rates of obesity in babies whose mothers had diabetes in pregnancy and higher risks for the mother to develop type 2 diabetes. Prevention of diabetes in pregnancy is ideal. This study will investigate if probiotics are an effective method to reduce rates of diabetes in pregnancy in overweight and obese women.
Trial website
www.springgdm.net
Trial related presentations / publications
28. Dekker Nitert, M., Barrett, H.L., Foxcroft, K., Tremellen, A., Wilkinson, S., Lingwood, B., Tobin, J.M., McSweeney, C., O’Rourke, P., McIntyre, H.D., Callaway, L.K. (2013). SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women. BMC Pregnancy and Childbirth 13:50
Public notes

Contacts
Principal investigator
Name 33416 0
Prof Leonie K Callawy
Address 33416 0
Northern Academic Cluster and Deputy Head, School of Medicine, The University of Queensland & Specialist in Obstetric and Internal Medicine, Royal Brisbane and Women's Hospital
Health Sciences Building, Royal Brisbane and Women’s Hospital, Butterfield St, Herston QLD 4029
Country 33416 0
Australia
Phone 33416 0
+61 7 3346 5273
Fax 33416 0
Email 33416 0
l.callaway@uq.edu.au
Contact person for public queries
Name 16663 0
Prof A/Prof Leonie Callaway
Address 16663 0
Level 9
Health Sciences Building
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 16663 0
Australia
Phone 16663 0
+61 7 3346 5273
Fax 16663 0
Email 16663 0
l.callaway@uq.edu.au
Contact person for scientific queries
Name 7591 0
Dr Marloes Dekker Nitert
Address 7591 0
Level 9
Health Sciences Building
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 7591 0
Australia
Phone 7591 0
+61 7 3346 5418
Fax 7591 0
Email 7591 0
m.dekker@uq.edu.au

No data has been provided for results reporting
Summary results
Not applicable