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Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
Sponsor: Riphah International University
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-07
Completion Date
2027-06
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
GRP 1 Tab metformin
Tab metformin 500 mg TDS for 12 weeks
GRP 2 Inj insulin
Inj insulin s/c BD for 12 weeks
GRP 3 Tab metformin + HI flora sachet
Tab metformin 500 mg TDS + HI flora sachet OD for 12 weeks
GRP 4 Inj insulin + HI flora sachet
Inj insulin s/c BD + HI flora sachet OD for 12 weeks
Locations (1)
Pakistan Railway Hospital
Rawalpindi, Punjab Province, Pakistan