MedTrace Logo

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

NCT07645001 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes

Interventions

OTHER

GRP 2 Inj insulin

Inj insulin s/c BD for 12 weeks

OTHER

GRP 3 Tab metformin + HI flora sachet

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

OTHER

GRP 4 Inj insulin + HI flora sachet

Inj insulin s/c BD + HI flora sachet OD for 12 weeks

OTHER

GRP 1 Tab metformin

Tab metformin 500 mg TDS for 12 weeks

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Jawaria Iftikhar, phd* · Riphah International University

  • Akbar Waheed, PHD · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-29
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645001 on ClinicalTrials.gov