NIPH Clinical Trials Search

JRCT ID: jRCTs041210014

Registered date:28/04/2021

PPP trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSpontaneous preterm birth (22 - 36 weeks of gestation)
Date of first enrollment26/05/2021
Target sample size345
Countries of recruitment
Study typeInterventional
Intervention(s)Single arm:The study medicine (6 tablets(3g) of Bio-three combination OD tablet /day) will be started in 3 divided doses between 10 weeks 0 day and 14 weeks 6 days of pregnancy. Treatment will be continued until delivery or 36 weeks and 6 days of gestation.


Primary OutcomeThe presence of spontaneous preterm delivery less than 37 weeks.
Secondary Outcome1.The presence by which pregnancy for less than 34 weeks is spontaneous preterm delivery. 2.The presence by which pregnancy for less than 28 weeks is repeated spontaneous preterm delivery. 3.The ratio of the butyric acid bacteria including the inside Clostridium genus of the intestinal bacteria (NGS). 4.The rate of bacterial vaginosis (the value in Nugent score). 5.The rate of cases with short cervix (<25mm) at 21-24 weeks. 6.The presence of histological chorioamnionitis, funisitis. 7.The presence of stillbirth. 8.The presence of neonatal morbidity [delivery weeks, birth weight, NICU hospitalization, neonatal death, serious complications (RDS, PVL, CLD according to the type, IVH according to the type, NEC)]. 9.Constipation evaluated by BFS and CSS. 10.Medical expenses. 11.Medication.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 43age old
Include criteria1.Pregnant women less than 14 weeks pregnant with a history of spontaneous preterm birth (22 - 36 weeks of gestation). 2.Pregnant women aged 20 to 43 at the time of consent.(After April, 2022, pregnant women aged 18 to 43) 3.Pregnant women with written consent.
Exclude criteria(1)Multiple pregnancy (2)pregnant women with severe physical disability (3)pregnant women with allergy of biothree (4)pregnant women who had used biothree within 2 weeks (5)pregnant women with a history of conization (6)pregnant women with uterine anomaly (7)pregnant women with cervical polyp and apparent genital bleeding less than 10 weeks (8)pregnant women with subchorionic hematoma and apparent genital bleeding (9)pregnant women who have used steroid (10)pregnant women with diabetes (11)pregnant women with autoimmune disease (12)pregnant women complicated malignancy (13)pregnant women with fetal anomaly (14)pregnant women who take part in another clinical study (15)pregnant women who is judged to be inappropriate for this study by principal investivator

Related Information


Public contact
Name Satoshi Yoneda
Address 2630 Sugitani, Toyama Toyama Japan 930-0194
Telephone +81-76-434-7357
Affiliation Toyama university hospital
Scientific contact
Name Satoshi Yoneda
Address 2630 Sugitani, Toyama Toyama Japan 930-0194
Telephone +81-76-434-7357
Affiliation Toyama university hospital