Next Article in Journal
Comprehensive Analysis of the Proteome of S. cerevisiae Wild-Type and pdr5Δ Cells in Response to Bisphenol A (BPA) Exposure
Next Article in Special Issue
Gut Microbiome Health in Farm Animals and Fish: Implications for Human Health and the Risk of Gastrointestinal Diseases
Previous Article in Journal
A Multiplex Polymerase Chain Reaction Assay for the Detection of Herpes Simplex Virus, Cytomegalovirus, and Varicella-Zoster Virus in Cerebrospinal Fluid
 
 
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Article

Evaluation of Faecal Microbiota Following Probiotics in Infants of Mothers with Gestational Diabetes Mellitus Trial: Protocol for Double-Blind Placebo-Controlled Randomized Trial

by
Gayatri Athalye-Jape
1,2,3,*,
Chandra Prakash Rath
1,2,
Harshad Panchal
1,
Archita Mishra
3,4,
Dorothy Graham
5 and
Sanjay Patole
1,2,*
1
Department of Neonatology, King Edward Memorial Hospital, Perth, WA 6008, Australia
2
School of Medicine, The University of Western Australia, Crawley, WA 6009, Australia
3
The Kids Research Institute, Perth, WA 6009, Australia
4
Indian Institute of Sciences, University of Sydney, Sydney, NSW 2050, Australia
5
Department of Obstetric Medicine, King Edward Memorial Hospital, Perth, WA 6008, Australia
*
Authors to whom correspondence should be addressed.
Microorganisms 2025, 13(1), 112; https://doi.org/10.3390/microorganisms13010112
Submission received: 31 October 2024 / Revised: 24 December 2024 / Accepted: 7 January 2025 / Published: 8 January 2025
(This article belongs to the Special Issue Intestinal Dysbiosis: 2nd Edition)

Abstract

(1) Background: The incidence of gestational diabetes mellitus (GDM) is rising globally. The current evidence indicates that GDM, especially in conjunction with maternal overweight, can alter the composition of infants’ gut microbiota, potentially increasing the risk of inflammatory diseases, metabolic disorders, and neurodevelopmental issues later in life. Probiotic supplantation early in life might establish eubiosis and mitigate future complications. To best of our knowledge, no study has evaluated the effects of probiotics on gut dysbiosis in the infants of mothers with GDM. (2) Methods: This study will be a single-centre, double-blind, randomized, placebo-controlled trial enrolling sixty neonates born after 35 weeks of gestation to mothers with GDM. The participants will be randomly assigned to receive either a triple-strain probiotic or a placebo for four months. The primary objective is to assess the effectiveness of probiotic supplementation in correcting gut dysbiosis in the infants of mothers with GDM at four months of age. Faecal microbiome composition shall be estimated using 16SrRNA and shotgun sequencing. The secondary outcomes will include the quantification of faecal short-chain fatty acids at birth and at four months, as well as growth and developmental assessments at four, twelve, and twenty-four months. (3) Trial registration: This trial protocol is registered (ACTRN12624000930583p) in the Australian Clinical Trials registry (ANZCTR).
Keywords: probiotics; infants of diabetic mothers; gestational diabetes; microbiome probiotics; infants of diabetic mothers; gestational diabetes; microbiome

Share and Cite

MDPI and ACS Style

Athalye-Jape, G.; Rath, C.P.; Panchal, H.; Mishra, A.; Graham, D.; Patole, S. Evaluation of Faecal Microbiota Following Probiotics in Infants of Mothers with Gestational Diabetes Mellitus Trial: Protocol for Double-Blind Placebo-Controlled Randomized Trial. Microorganisms 2025, 13, 112. https://doi.org/10.3390/microorganisms13010112

AMA Style

Athalye-Jape G, Rath CP, Panchal H, Mishra A, Graham D, Patole S. Evaluation of Faecal Microbiota Following Probiotics in Infants of Mothers with Gestational Diabetes Mellitus Trial: Protocol for Double-Blind Placebo-Controlled Randomized Trial. Microorganisms. 2025; 13(1):112. https://doi.org/10.3390/microorganisms13010112

Chicago/Turabian Style

Athalye-Jape, Gayatri, Chandra Prakash Rath, Harshad Panchal, Archita Mishra, Dorothy Graham, and Sanjay Patole. 2025. "Evaluation of Faecal Microbiota Following Probiotics in Infants of Mothers with Gestational Diabetes Mellitus Trial: Protocol for Double-Blind Placebo-Controlled Randomized Trial" Microorganisms 13, no. 1: 112. https://doi.org/10.3390/microorganisms13010112

APA Style

Athalye-Jape, G., Rath, C. P., Panchal, H., Mishra, A., Graham, D., & Patole, S. (2025). Evaluation of Faecal Microbiota Following Probiotics in Infants of Mothers with Gestational Diabetes Mellitus Trial: Protocol for Double-Blind Placebo-Controlled Randomized Trial. Microorganisms, 13(1), 112. https://doi.org/10.3390/microorganisms13010112

Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here.

Article Metrics

Back to TopTop