Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GRP 1 Tab metformin, GRP 2 Inj insulin, GRP 3 Tab metformin + HI flora sachet, GRP 4 Inj insulin + HI flora sachet.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other GRP 1 Tab metformin
Tab metformin 500 mg TDS for 12 weeks - 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
Primary outcome measures
- Fasting blood glucose levels [Time frame: 12 week]
- Fasting Serum Insulin Levels [Time frame: 12 week]
- Homeostatic Model Assessment of Insulin Resistance [Time frame: 12 week]
- Glycated Hemoglobin [Time frame: 12 week]
Secondary outcome measures (11)
- High-sensitivity C-reactive protein [Time frame: 12 week]
- Neutrophil-to-Lymphocyte ratio [Time frame: 12 week]
- Adiponectin [Time frame: 12 week]
- fetal Abdominal Circumference [Time frame: 12 week]
- thickness of placenta [Time frame: 12 week]
- Amniotic Fluid Index [Time frame: 12 week]
- Gestational age at delivery [Time frame: 39 weeks]
- Mode of delivery [Time frame: 39 week]
- Birth weight [Time frame: 39 week]
- Apgar score [Time frame: 39 week]
- Rate of neonatal intensive care unit admission [Time frame: 39 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Pakistan Railway Hospital — Rawalpindi
Identifiers
NCT: NCT07645001 · IIMC/IRB/26/1037 Jawaria