RecruitingNot ApplicableNCT07645001

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


Sponsor

Riphah International University

Enrollment

200 participants

Start Date

Jul 29, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying GRP 1 Tab metformin, GRP 2 Inj insulin, and others for people with gestational diabetes. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERGRP 1 Tab metformin

Tab metformin 500 mg TDS for 12 weeks

OTHERGRP 2 Inj insulin

Inj insulin s/c BD for 12 weeks

OTHERGRP 3 Tab metformin + HI flora sachet

Tab metformin 500 mg TDS + HI flora sachet OD for 12 weeks

OTHERGRP 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

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NCT07645001


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