Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus

Summary

1. To compare the effects of metformin, insulin, and their combination with multistrain probiotics on glycemic control and insulin resistance in women with gestational diabetes mellitus (GDM), assessed by FPG, HbA1c, fasting insulin, and HOMA-IR. 2. To compare the effects of metformin, insulin, and their combination with multistrain probiotics on inflammatory biomarkers in women with GDM. 3. To determine the effect of multistrain probiotic supplementation alongside standard therapy on maternal and neonatal outcomes, including gestational age at delivery, mode of delivery, birth weight, Apgar score, and NICU admission.

Eligibility

Inclusion Criteria:

* Pregnant women (18-45 years of age).
* Diagnosed with GDM between 18-26 weeks of gestation.
* Singleton pregnancy. (Multiple gestations carry inherently higher risks like preterm birth, growth restriction and neonatal morbidity, Inclusion may introduce confounding thus restricting singleton pregnancies ensures population homogeneity).

Exclusion Criteria:

* Pre-existing diabetes mellitus.
* Pregnancy induced hypertension.
* Chronic gastrointestinal, hepatic, or renal disease.
* Use of antibiotics or probiotics within the previous 4 weeks.
* Multiple pregnancy.
* Pregnancy with known fetal anomalies.

Conditions2

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