Probiotics for the prevention of gestational diabetes in overweight and obese women.

Randomized placebo controlled trial of probiotics in overweight and obese women to assess the prevention of gestational diabetes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001208998

Acronym

SPRING

Enrollment

540

Registered

2011-11-23

Start date

2012-11-01

Completion date

2016-03-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

BMI greater than 25 Can read and understand English Less than 16 weeks pregnant

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

Outcome results