NCT07645001招募中不适用
Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
研究概览
简要总结
- 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.
- To compare the effects of metformin, insulin, and their combination with multistrain probiotics on inflammatory biomarkers in women with GDM.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
GRP 1 Tab metformin
Active Comparator
干预措施: GRP 1 Tab metformin (Other)
GRP 3 Tab metformin + HI flora sachet
Experimental
干预措施: GRP 3 Tab metformin + HI flora sachet (Other)
GRP 4 Inj insulin + HI flora
Experimental
干预措施: GRP 4 Inj insulin + HI flora sachet (Other)
GRP 2 Inj insulin
Active Comparator
干预措施: GRP 2 Inj insulin (Other)
研究者
研究点 (2)
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