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Study aim
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Comparison of abnormal OGTT in probiotic capsule consumers and control group in high risk pre-diabattic women.
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Design
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A Phase 3 clinical trial, with a control group, three blind, randomized allocation, 243 eligible pregnant women. Cluster sampling convenience method on pregnant women with high risk pre-diabetics referred to Mashhad health centers.
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Settings and conduct
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Packaging and encodings of capsules will be done by the pharmacist. The study will be triple blind. Research units will be pregnant women referred to Mashhad health centers who are eligible to enter the study. The intervention will be performed within 70 days(12 week) and then at 26-28 weeks in all three groups, OGTT (oral glucose tolerance test) will be measured and evaluated.
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Participants/Inclusion and exclusion criteria
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Willingness to participate, Reading and writing literacy, no history of cow's milk allergy, having a contact number, being pre-diabetics, The gestational age between 14 and 16 weeks, lack of continuous antibiotic use in the last 3 months, absence of immune disorders or medical illness, Lack of pregnancy by in vitro fertilization, normal screening tests for fetal abnormalities in the first stage, Single pregnancy, no decision to terminate pregnancy, no smoking, no stressful incident in the last 3 months, no severe mental illness.
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Intervention groups
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Routine care includes exercise and Pre-diabetes diet in all three groups of probiotic, placebo and control. In the Probiotic Group 1 probiotic capsule daily and in the placebo group 1 placebo for 12 weeks from 14-16 until 26-28 weeks of gestation. In the control group, routine health care will receive, include education pre-diabettic diet and exercise.
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Main outcome variables
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Abnormal OGTT