A Probiotic Based Intervention in Pregnancies Complicated by GDM

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

December 31, 2029

Conditions
Gestational Diabetes Mellitus (GDM)Microbiome, Human
Interventions
DIETARY_SUPPLEMENT

5-strain probiotic plus prebiotic natural health product

"The investigational product is a 5-strain probiotic plus prebiotic natural health product for patients with Type 2 diabetes. Other ingredients include oligofructose, grape food color, magnesium stearate, silica and a delayed release capsule.~Recommended storage is in a refrigerated environment at approximately 4°C. The product should not be frozen. It is recommended that the product be used within 2 months after opening the bottle. Participants are asked to take 2 capsules daily with food, 1 in the morning and 1 in the evening. There is ≥ 2 billion AFU per dose in total."

OTHER

Placebo

"Ingredients include oligofructose, grape food color, magnesium stearate, silica and a delayed release capsule.~Recommended storage is in a refrigerated environment at approximately 4°C. The product should not be frozen. It is recommended that the product be used within 2 months after opening the bottle. Participants are asked to take 2 capsules daily with food, 1 in the morning and 1 in the evening."

Trial Locations (1)

K7L2V7

Queen's University & Kingston Health Sciences Centre, Kingston

All Listed Sponsors
lead

Queen's University

OTHER