A study on effect of maternal synbiotic supplementation during pregnancy on maternal, fetal and fetomaternal interface (placenta) miRNA profiles in women receiving IFA supplementation, a randomised controlled pilot trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a single-centre, randomized, parallel group, active-controlled pilot trial designed to evaluate the effect of maternal synbiotic supplementation during pregnancy on maternal, fetal and fetomaternal interface (placental) microRNA (miRNA) expression profiles in women receiving routine iron and folic acid (IFA) supplementation. A total of 60 pregnant women in their first trimester will be randomly allocated in a 1:1 ratio to receive either routine IFA supplementation along with synbiotic supplementation (native yogurt and banana starch) or routine IFA supplementation alone. Participants will be followed from enrollment until delivery. Maternal blood, placental tissue, cord blood, fecal samples and breast milk samples will be collected at predefined time points to assess changes in cellular miRNA expression and maternal gut microbiome composition. The study aims to generate pilot data on the interaction between maternal nutrition, gut microbiome and epigenetic regulation during pregnancy, which may inform future larger interventional studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •In their first trimester
- •Singleton pregnancy (confirmed by ultrasound)
- •On Iron and folic acid supplementation
- •Not on any probiotic supplements
- •Willing to consent
- •Available and willing to the follow-up visit.
排除标准
- •Having high risk pregnancy(diabetes, hypertension, placenta previa, placental abruption, cervical insufficiency and history adverse outcomes during earlier pregnancy)
- •Known gastrointestinal diseases(chronic diarrhea, ulcerative colitis, Crohns disease) 3.Severe Anemia (Hb less than 7gm per dl 4.Any chronic disease (cardiovascular, hepatic, renal disease, COPD/chronic asthma, immune disorder) 5.Do not comply with iron supplementation.
- •6.Antibiotic use (oral or systemic) in the last three months.
- •7.Not willing/able to follow the protocol 8.Not giving consent.
研究者
Dr Balamurugan Ramadass
AIIMS, Bhubaneswar