Probiotic-augmented therapy for gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares metformin, insulin, and their combination with multistrain probiotics in women with gestational diabetes diagnosed between 18 and 26 weeks of pregnancy. Outcomes include glycemic measures (fasting plasma glucose, HbA1c, fasting insulin, and insulin resistance), inflammatory biomarkers, and maternal and neonatal outcomes such as delivery timing, mode, birth weight, Apgar scores, and NICU admission. Participants are singleton pregnancies, aged 18–45, without pre-existing diabetes or major comorbidities, and probiotics are added as an adjunct to standard therapy. The trial is conducted at Pakistan Railways Hospital in Rawalpindi and is led by Riphah International University. Probiotic supplementation is being evaluated for potential additive benefits alongside conventional antidiabetic treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

Exclusion Criteria:

* Pre-existing diabetes mellitus.
* Pregnancy induced hypertension.
* Chronic gastrointestinal, hepatic, or renal disease.
* Use of antibiotics or probiotics within the previous 4 weeks.
* Multiple pregnancy.
* Pregnancy with known fetal anomalies.

Where it's running

• Pakistan Railway Hospital
  Rawalpindi, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Jawaria Iftikhar, phd* — Riphah International University
• Study coordinator: Jawaria Iftikhar, phd*
• Email: jawaria.iftikhar@riphah.edu.pk
• Phone: 03004219529

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.