Probiotics in Pregnancy Study (ProP Study)

A randomised controlled trial of probiotics in pregnancy to reduce maternal glucose in obese and gestational diabetic women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97241163

Enrollment

300

Registered

2012-03-09

Start date

2012-02-20

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, obesity, gestational diabetes mellitus Pregnancy and Childbirth Diabetes mellitus in pregnancy

Interventions

Part A - Prevention of GDM: 1. At recruitment (<22 weeks gestation): 1.1. Written informed consent obtained 1.2. Weight, height, early pregnancy BMI recorded 1.3. Healthy eating dietary advice provide

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 30/07/2012: Part A - prevention of GDM: 1. BMI between 30.0 and 39.9 Kg/m2 2. Gestational age = 22 weeks 3. Age 18 - 45 years 4. Adequate understanding of the English language Part B - treatment of GDM: 1. BMI in any category 2. Gestational age <36 weeks 3. New diagnosis of GDM or impaired glucose tolerance (IGT) 4. Age 18 - 45 years 5. Adequate understanding of the English language Previous inclusion criteria until 30/07/2012: Part B - treatment of GDM: 3. New diagnosis of GDM (not in previous pregnancy)

Exclusion criteria

Exclusion criteria: Part A - prevention of GDM: 1. BMI 39.9 Kg/m2 2. Age 45 years 3. Gestational age >22 weeks 4. Foetal anomaly 5. Twin pregnancy 6. Inadequate understanding of English 7. Diabetes - type 1, type 2, newly diagnosed GDM or previous GDM Part B - treatment of GDM: Age 45 years 1. Gestational age >36 weeks 2. Foetal anomaly 3. Twin pregnancy 4. Inadequate understanding of English 5. GDM diagnosis in previous pregnancy or type 1 or 2 diabetes

Design outcomes

Primary

Measure	Time frame
Obese pregnant mothers (Part A): Difference between the control and probiotic groups in fasting blood glucose Gestational diabetes (Part B): Difference between the control and probiotic groups in fasting blood glucose	—

Secondary

Measure	Time frame
Part A - differences between the 2 groups: 1. Incidence of gestational diabetes 2. Neonatal anthropometry Part B are the following differences between the 2 groups: 1. Requirement for insulin 2. Gestation at commencement of insulin and amount of insulin required 3. Neonatal anthropometry	—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026