To study the transit of beneficial bacteria from mother to infant

Not Applicable

Completed

• Conditions: Probiotics, pregnancy, Bifidobacteria, microbiome; Pregnancy and Childbirth

• Registration Number: ISRCTN53023014
• Lead Sponsor: niversity College Dublin

Brief Summary

2023 Preprint results in https://doi.org/10.1101/2023.03.28.23287708 (added 31/03/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37720155/ Secondary analysis (added 18/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-18
• Study Completion: 2019-12-31
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Participant inclusion criteria as of 14/11/2018:
1. Pregnant women over the age of 18, capable of giving informed consent
2. With adequate understanding of the English language and an understanding of the study to enable them to give informed consent to participate
3. With a Body Mass Index of =18.5kg/m2 and =35kg/m2

Previous participant inclusion criteria:
1. Pregnant women over the age of 18, capable of giving informed consent
2. With adequate understanding of the English language and an understanding of the study to enable them to give informed consent to participate
3. With a Body Mass Index of =20kg/m2 and =35kg/m2

Exclusion Criteria

1. A history of gestational diabetes in a previous pregnancy
2. Pre-gestational diabetes e.g. Type 1 or Type 2 diabetes
3. A multiple pregnancy or fetal anomaly
5. A poor standard of English
6. A previous perinatal death

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of the supplemented bifidobacterial strain in the infant’s stool in the 1st week postpartum, at 1 month postpartum and at 3 months postpartum. To measure this the infant stool will be analysed for the presence of the supplemented bifidobacterial strain.

Secondary Outcome Measures

Name	Time	Method
Differences in the following between the probiotic and placebo groups: <br>1. Maternal lipids<br>2. Maternal insulin resistance as measured by fasting glucose and HOMA-IR<br>3. Maternal C Reactive Peptide<br>Maternal bloods will be taken in early (approx. 16 weeks gestation) and late (approx. 34 weeks gestation) pregnancy and will be analysed for these metabolic parameters.