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

RecruitingNAAges 18 Years - 45 YearsFemaleRiphah International University
NCT07645001 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • GRP 1 Tab metformin
  • GRP 2 Inj insulin
  • GRP 3 Tab metformin + HI flora sachet
  • GRP 4 Inj insulin + HI flora sachet
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Where

1 site
Pakistan Railway Hospital
Rawalpindi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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