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

Sponsor
Riphah International University
Study ID
NCT07645001
Status
Recruiting
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Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • GRP 1 Tab metformin — OTHER
    Tab metformin 500 mg TDS for 12 weeks
  • GRP 2 Inj insulin — OTHER
    Inj insulin s/c BD for 12 weeks
  • GRP 3 Tab metformin + HI flora sachet — OTHER
    Tab metformin 500 mg TDS + HI flora sachet OD for 12 weeks
  • GRP 4 Inj insulin + HI flora sachet — OTHER
    Inj insulin s/c BD + HI flora sachet OD for 12 weeks

Study Details

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 Dates

First listed
Jun 12, 2026
Start date
Jul 29, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: GRP 1 Tab metformin
  • Active Comparator: GRP 2 Inj insulin
  • Experimental: GRP 3 Tab metformin + HI flora sachet
  • Experimental: GRP 4 Inj insulin + HI flora

Primary Outcome Measure

Fasting blood glucose levels [ Time Frame: 12 week ]

Central Contacts

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