Nachum 2019.

Study name	The effect of oral probiotics on glycaemic control of women with gestational diabetes mellitus
Methods	Randomised, double‐blind, placebo‐controlled trial, phase 4.
Participants	Inclusion: pregnant women diagnosed with GDM from 13 to 32.6 weeks, > 18 years old, singleton pregnancy.
Interventions	Dietary supplement (Femina II) 2 capsules per day until delivery Placebo: 2 capsules per day until delivery.
Outcomes	Primary outcomes: the rate of women who will require pharmacotherapy for glycaemic control. The mean value of the daily glucose charts after 2 weeks of treatment with the study products. Secondary outcomes: the rate of women with controlled diabetes; mean daily glucose charts; mean daily pre‐prandial glucose levels; mean daily postprandial glucose levels; level of glycated molecules; rate of: women with mean pre‐prandial values ≥ 95 mg/dL, mean post‐prandial values ≥ 130 mg/dL, and mean daily glucose > 100 mg/dL; caesareans; labour inductions; birthweight > 4000 g/> 90th percentile; admission to NICU; 1‐minute and 5‐minute Apgar score; neonatal hypoglycaemia; neonatal hypomagnesaemia; cord blood PH levels; neonatal malformations and developmental disorders; birthweight; head circumference; maternal adverse effects; duration of time until pharmacotherapy for glycaemic control is indicated.
Starting date	Not yet recruiting
Contact information	Zohar Nachum; nachum_zo@clalit.org.il
Notes	Objectives: to examine the effect of a mixture of probiotic strains given daily on maternal glycaemic parameters, and pregnancy outcomes among women with GDM.

CFU: colony‐forming units; GDM: gestational diabetic mellitus; IGT: impaired glucose tolerance; NICU: neonatal intensive care unit;OGTT: oral glucose tolerance test; PCR: polymerase chain reaction.