None listed
Conditions
Brief summary
The purpose of the study is to establish if probiotics taken in pregnancy can reduce the incidence of gestational diabetes (GDM) in women who are at increased risk of GDM. The study hypothesis is the administration of probiotics to pregnant women at risk of gestational diabetes from 12 weeks of gestation reduces the incidence of GDM diagnosed at 26-28 weeks gestation. The study is a prospective, double-blinded randomized controlled trial. Women attending public hospital antenatal services who are at increased risk of developing GDM will be invited to participate. Participants will be randomly allocated to either the control group receiving a placebo or the intervention group receiving probiotics daily from booking in appointment (usually approx. 12 weeks gestation) until the Oral Glucose Tolerance Test (routinely done at 26-28 weeks gestation). Women. The primary outcome is incidence of GDM in the control and intervention groups..
Interventions
Women will be recruited to the study at their booking-in appointment with the antenatal clinic (usually at 12 week's pregnancy). Participating women will be randomised to the intervention or control group. The intervention group will be given probiotic capsules to be taken once daily from enrolment until the results are received from their Glucose Tolerance Test, which is conducted at their 26-28 week antenatal care visit. The probiotic will contain a combination of strains lactobacillus rhamnos
Women will be recruited to the study at their booking-in appointment with the antenatal clinic (usually at 12 week's pregnancy). Participating women will be randomised to the intervention or control group. The intervention group will be given probiotic capsules to be taken once daily from enrolment until the results are received from their Glucose Tolerance Test, which is conducted at their 26-28 week antenatal care visit. The probiotic will contain a combination of strains lactobacillus rhamnosus and Bifidobacterium animalis ssp lactis and/or Bifidobacterium breve and Bifidobacterium longum as these are previously well researched strains specific for pregnancy. Lactobacillus rhamnosus and Bifidovacterium animalis ssp lactis have been shown to influence glucose metabolism through their immunoregulatory properties. The probiotic and placebo will be manufactured and supplied by Metagenetics (Aust) Pty Ltd. Given the fragile nature of the microbes in probiotics, women will be instructed to keep the capsules in a refrigerator and to avoid taking them within 10 minutes of consuming hot food or fluid. Adherence to the intervention will be monitored by counting the number of capsules in bottles returned by participants at their 26-28 week antenatal clinic visit. As per standard care, at their 26-28 antenatal clinic, all women will complete an Oral Glucose Tolerance Test. Completion of the test marks the end of their participation in the study.
Sponsors
Dr Anushika Samarage
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
All pregnant women >10 weeks gestation, in a singleton pregnancy at increased risk of gestational diabetes as per the Australasian Diabetes in Pregnancy Society (ADIPS) criteria will be eligible for the study: • Previous GDM • Maternal age 18 years to 40 years • Family history of diabetes (1st degree relative with diabetes or a sister with GDM) • BMI over 35kg/m2 • Previous macrosomia (baby birth weight over 4500g or over 90th centile) • Polycystic ovarian syndrome
Exclusion criteria
• Not being able to read and understand English – unable to provide informed consent. • Age <18 years • Pregnancy >16 weeks gestation at recruitment • Known pre-existing diabetes, impaired fasting glucose or impaired glucose tolerance • GDM prior to recruitment as diagnosed by early pregnancy glucose testing – Early pregnancy glucose testing routinely done for women at increased risk of GDM • Medications likely to influence glucose metabolism – metformin, glucocorticoids, immunosuppressants • Medical conditions with altered glucose metabolism – Cushing/s syndrome, hepatic cirrhosis • Known major fetal anomaly on ultrasound • Known current ingestion of probiotics via capsules or sachets • Antibiotic use during the study period
Outcome results
None listed