Nabhani 2018.

Study characteristics
Methods	Double‐blind, placebo‐controlled, randomised clinical trial
Participants	Pregnant women with GDM (n = 95). Setting Diabetes East Health Centre, Ahwaz, Iran Dates of study January 2015 and September 2016 Inclusion criteria Pregnant women aged 18‐40 years, diagnosed with GDM according to Diabetes Association guideline criteria, by a 1‐step 2‐hour, 75 g OGT at 24‐28 weeks' gestation. (Fasting ≥ 92 mg/dL, 1 hour ≥ 180 mg/dL, 2 hour ≥ 153 mg/dL.) Exclusion criteria Use of anti‐diabetic drugs, (metformin, insulin) Current smokers, placenta abruption, pre‐eclampsia, eclampsia, hypo/hyperthyroidism, kidney, liver, inflammatory or immunodeficiency diseases, thyroid disorders, lactose intolerant. Also using any kinds of oestrogen, progesterone, cholesterol‐lowering drugs or diuretics; consuming any type of probiotics in the past 1 month prior to GDM diagnosis. Also if currently taking probiotic food or supplements during study period, taking antibiotics or glucocorticoids.
Interventions	Synbiotic capsule (LactoFem) contained 500 mg of Lactobacillus probiotic strains consisting of: L. acidophilus (5 x 1010 CFU/g), L. plantarum (1.5 x 1010 CFU/g), L. fermentum (7 x 109 CFU/g), L. gasseri (2 x 1010 CFU/g) and 38.5 mg of FOS as prebiotic substance. Other components included lactose (300 mg), magnesium stearate, talc, colloidal silicon dioxide (each of them 5.5 mg), flavourings and sweeteners that have neutral effects (n = 48). Placebo capsules contained similar as above: lactose (300 mg), magnesium stearate, talc, colloidal silicon dioxide (each of them 5.5 mg), flavourings and sweeteners that have neutral effects) without the probiotics. The appearance, texture, weight and smell of capsules and packages were identical for both synbiotics and placebo and they were only different in their codes A or B that were placed on their packs (n = 47).
Outcomes	Biochemical factors of FPG, serum insulin, HOMA‐IR, quantitative insulin sensitivity check index (QUICKI), lipid profile (LDL‐C, HDL‐C, TG) and TC, TAC and blood pressure indices.
Notes	Source of funding Tabriz University of Medical Sciences, Tabriz, Iran and Nutrition Research Center. (LactoFem) were produced by ZistTakhmir Pharmaceutical Company in Tehran, Iran, and registered at the Food and Drug Administration. Conflicts of interest: No conflicts of interest reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random sequence by random allocation software. Computer block randomisation
Allocation concealment (selection bias)	Unclear risk	All researchers were unaware of the allocation.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The appearance, texture, weight and smell of capsules and packages were identical for both synbiotics and placebo and they were only different in their codes A or B that were placed on their packs
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All researchers were blinded to the allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Synbiotic: discontinued n = 3 (1 preterm labour before 3 weeks, 1 change of mind, 1 did not consume supplements according to plan). Placebo group – discontinued intervention n = 2 (1 changed mind, 1 preterm labour before 35 weeks)
Selective reporting (reporting bias)	Unclear risk	No retrospective trial registration. Insufficient information to judge if pre‐specified outcomes are reported in full.
Other bias	Low risk	Analysis of dietary intakes showed that there were no significant differences between the 2 groups for the macro‐ and micronutrient intakes, except for the energy, protein and total fat intakes (P < 0.05); thus, final analyses were adjusted for the measures of energy intake, BMI and baseline values.

BG: blood glucose;BMI: body mass index; BP: blood pressure; CFU: colony‐forming units; CRP: C‐reactive protein; erythrocyte GPX: red blood cell glutathione peroxidase; erythrocyte SOD: red blood cell superoxide dismutase; Fe: iron; FOS: Fructo‐oligosaccharides; FPG: fasting plasma glucose; GDM: gestational diabetes mellitus; GI: gastrointestinal; GSH: glutathione; HDL: high‐density lipoprotein; HOMA: Homeostasis Model Assessment; IGT: impaired glucose tolerance; IL‐6: interleukin 6;LGA: large‐for‐gestational age; MDA: malondialdehyde; MET: metabolic equivalents; MFA: monounsaturated fatty acids; Mg: magnesium; NICU: neonatal intensive care unit; NO: nitric oxide; LDL: low‐density lipoprotein; OGTT: oral glucose tolerance test; PUFA: polyunsaturated fatty acids; SFA: saturated fatty acids; TAC: total antioxidant capacity; very low‐density lipoprotein; TAG: triglycerides; TNF: tumour necrosis factor; ZN: zinc.