Corbett Gillian A, Corcoran Siobhan, Feehily Conor, Soldati Benedetta, Rafferty Anthony, MacIntyre David A, Cotter Paul D, McAuliffe Fionnuala M
UCD Perinatal Research Centre, UCD School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland; National Maternity Hospital, Dublin 2, Ireland.
School of Infection and Immunity, University of Glasgow, Glasgow G12 8TA, United Kingdom.
Contemp Clin Trials. 2025 Feb;149:107776. doi: 10.1016/j.cct.2024.107776. Epub 2024 Dec 17.
Effective spontaneous preterm birth (sPTB) prevention is an urgent unmet clinical need. Vaginal depletion of Lactobacillus crispatus is linked to sPTB. This trial will investigate impact of an oral Lactobacillus spp. probiotic product containing an L. crispatus strain with other Lactobacilli spp., on the maternal vaginal and gut microbiome in pregnancies high-risk for sPTB.
A double-blind, placebo-controlled, randomised trial will be performed at the National Maternity Hospital Dublin, Ireland. Inclusion criteria are women with history of sPTB or mid-trimester loss, cervical surgery (cone biopsy or two previous large-loop-excision-of-transformation-zone) or uterine anomaly. The intervention is oral supplementation for twelve weeks with probiotic or identical placebo. The probiotic will contains: ◦ 4 billion CFU Lactobacillus crispatus Lbv 88(2x10CFU/Capsule) ◦ 4 billion CFU Lactobacillus rhamnosus Lbv 96(2x10CFU/Capsule) ◦ 0.8 billion CFU Lactobacillus jensenii Lbv 116(0.4x10CFU/Capsule) ◦ 1.2 billion CFU Lactobacillus gasseri Lbv 150(0.6x10CFU/Capsule). Investigators and participants will be blinded to assignment.
The primary outcome is detectable L. crispatus in the vaginal microbiome after twelve weeks of treatment, measured using high-throughput DNA sequencing. A total of 126 women are required to detect a 25 % increase in detectable L. crispatus. Secondary outcomes include impact of intervention on the gut microbiome and metabolome, rate of sPTB and mid-trimester loss, neonatal outcomes and maternal morbidity.
This randomised trial will investigate ability of an oral probiotic containing L. crispatus to increase its abundance in the vaginal microbiome, both directly by horizontal transfer and indirectly via microbiome and metabolome of the gut.
有效预防自发性早产（sPTB）是一项亟待满足的临床需求。卷曲乳杆菌在阴道内数量减少与自发性早产有关。本试验将研究一种含有卷曲乳杆菌菌株及其他乳杆菌属的口服益生菌产品，对有自发性早产高风险的孕妇阴道和肠道微生物群的影响。
将在爱尔兰都柏林国家妇产医院进行一项双盲、安慰剂对照的随机试验。纳入标准为有自发性早产或孕中期流产史、宫颈手术（锥形活检或两次先前的转化区大环状切除术）或子宫异常的女性。干预措施为口服益生菌或相同安慰剂，为期12周。益生菌将包含：
◦ 40亿CFU卷曲乳杆菌Lbv 88（2×10CFU/胶囊）
◦ 40亿CFU鼠李糖乳杆菌Lbv 96（2×10CFU/胶囊）
◦ 8亿CFU詹氏乳杆菌Lbv 116（0.4×10CFU/胶囊）
◦ 12亿CFU加氏乳杆菌Lbv 150（0.6×10CFU/胶囊）。研究人员和参与者将对分组情况不知情。
主要结局是治疗12周后，通过高通量DNA测序检测阴道微生物群中是否存在可检测到的卷曲乳杆菌。总共需要126名女性才能检测到可检测到的卷曲乳杆菌增加25%。次要结局包括干预对肠道微生物群和代谢组的影响、自发性早产和孕中期流产率、新生儿结局和孕产妇发病率。
这项随机试验将研究含卷曲乳杆菌的口服益生菌通过水平转移直接以及通过肠道微生物群和代谢组间接增加其在阴道微生物群中丰度的能力。
