None listed
Conditions
Brief summary
We hypothesize that giving oral probiotics to pregnant women during later part of pregnancy (>23weeks) will reduce GBS colonization at 35-37 weeks. This will thereby reduce the need of intrapartum antibiotics for women and infection blood tests for the babies. We also hypothesize that this will have additional beneficial effects on obstetric (GDM, preeclampsia, maternal infections), perinatal (premature rupture of membranes, preterm births) and neonatal outcomes (including reduction in neonatal sepsis).
Interventions
Intervention: Dietary Supplement: Probiotic dietary supplement or Placebo
Dietary Supplement: Probiotic genus & species Strain Active count. Lactobacillus acidophilus (helveticus) 4.35 Billion cfu, Lactobacillus rhamnosus 4.35 Billon cfu, Bifidobacterium longum 4.35 Billion cfu, Saccharomyces boulardii 1.95 Billon cfu, Other Names: -Gastrohealth 4 (Pharmacare Pty Ltd)
Other Names:
-Gastrohealth 4 (Pharmacare Pty Ltd)
Study Arm (s)
- Active Comparator: Probiotic dietary supplement, one capsu
Intervention: Dietary Supplement: Probiotic dietary supplement or Placebo Dietary Supplement: Probiotic genus & species Strain Active count. Lactobacillus acidophilus (helveticus) 4.35 Billion cfu, Lactobacillus rhamnosus 4.35 Billon cfu, Bifidobacterium longum 4.35 Billion cfu, Saccharomyces boulardii 1.95 Billon cfu, Other Names: -Gastrohealth 4 (Pharmacare Pty Ltd) Other Names: -Gastrohealth 4 (Pharmacare Pty Ltd) Study Arm (s) - Active Comparator: Probiotic dietary supplement, one capsule once daily until delivery. The investigators will schedule the women for routine monthly obstetric visits (more often if clinically required) during which time they will also meet with one of the investigators. The investigator at each monthly visit will provide an additional monthly allotment of 30 capsules. The capsule bottle from the previous cycle will be collected and dated if there are capsules remaining in the bottle. Remaining capsules will be counted and refrigerated for future use.
Sponsors
Fiona Stanley Hospital
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant women between 23-28 weeks gestation. 2. 18-55 years of age 3. Singleton gestation
Exclusion criteria
1. Pre-existing morbidity: * inflammatory bowel disease (Crohn's disease or ulcerative colitis); * stomach or duodenal ulcer; bowel resection, gastric bypass, and chronic indwelling venous, bladder, or gastric catheter, * Immunocompromised status (HIV +; malignancy; history of organ transplant; chronic steroid therapy; autoimmune disease requiring treatment during pregnancy, and other immunocompromised states); *Type 1 diabetes and type 2 diabetes; *congenital cardiac disease and cardiac valvular disease requiring antibiotic prophylaxis during procedure/labour; pulmonary disease (except mild asthma); *renal disease; * chronic hepatic disease (Hepatitis B, C); 2. Multi-foetal gestation. 3.Use of probiotics preparations in the 3 months prior to beginning of the study treatment or use of any additional probiotics preparations (other than study treatment) at any time during the study period (including over the counter food supplements such as Activia, other oral or vaginal probiotics products (BUT not including other common forms of yogurt). 4. Chronic (daily) use of broad spectrum antibiotics. 5. History of infant with GBS sepsis. 6. Foetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound 7. Anticipated delivery <35 weeks for maternal/foetal indication 8. Placenta Previa or accreta (with anticipated delivery prior to 35 weeks) 9. Women with a cognitive impairment, an intellectual disability or a mental illness
Outcome results
None listed