Karamali 2018.
| Study characteristics | ||
| Methods | Randomised, double‐blind, placebo‐controlled clinical trial | |
| Participants | Pregnant women with GDM (n = 60) Setting Akbarabadi clinic affiliated to Iran University of Medical Sciences (IUMS), Tehran, Iran. Dates of Study April 2016 and December 2016. Inclusion criteria Pregnant women diagnosed with GDM using the ADA guidelines, aged 18‐40 years (n = 30). Exclusion criteria Pre‐eclampsia, eclampsia, hypo‐ and hyperthyroidism, smokers and those with kidney or liver diseases and required commencing insulin therapy during intervention; taking any probiotic and/or synbiotic products including probiotic yogurt and kefir during the trial (n = 30). |
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| Interventions | Synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC‐M10785), L. casei strain T2 (IBRC‐M10783) and Bifidobacterium bifidum strain T1 (IBRC‐M10771) (2 × 109 CFU/g each) plus 800 mg inulin (HPX) or placebo for 6 weeks. | |
| Outcomes | Primary outcomes: inflammatory markers. Secondary outcomes: biomarkers of oxidative stress and pregnancy outcomes. |
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| Notes |
Funding: funded by a grant from the Vice Chancellor for Research, IUMS, Tehran, Iran Conflicts of interest: authors declared no conflict of interest. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was by computer‐generated random numbers. |
| Allocation concealment (selection bias) | Unclear risk | Unclear if researchers were aware of the upcoming allocation when recruiting participants. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind placebo‐controlled trial in the text |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no losses to follow‐up and all participant data were analysed. |
| 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 | None |