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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorRiphah International University

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

Pre-existing diabetes mellitus.

Pregnancy induced hypertension.

Chronic gastrointestinal, hepatic, or renal disease.

Use of antibiotics or probiotics within the previous 4 weeks.

Trial design

Treatments tested in this trial

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

Treatment groups

200 Participants
are divided into 4 treatment groups