Daily kefir during mid-pregnancy to see if it helps prevent gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized controlled trial, pregnant participants with singleton pregnancies begin daily kefir consumption around 14 weeks of gestation and continue until the 26-28 week visit, with usual prenatal care for controls. The study will measure glucose and insulin responses, monitor the emergence of gestational diabetes, and analyze changes in the maternal gut microbiome and metabolites, as well as postpartum outcomes such as breastmilk and infant size. The PEADS Lab at the University of New Brunswick leads the trial, enrolling participants who will attend four in-person visits and provide biological samples as per protocol. The study aims to determine whether kefir can favorably modulate metabolic health during pregnancy and influence maternal and infant outcomes. Secondary analyses will explore microbiome and metabolite profiles associated with kefir intake.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant individual with a singleton pregnancy
* 19 years and older of age
* Gestational age 14,3 weeks or less at enrolment
* Able and willing to attend four in-person study visits at the PEADS Laboratory: baseline, 18-20 weeks' gestation, 26-28 weeks' gestation, and 1 month postpartum
* Willing and able to comply with study group assignment, including daily consumption of 250 mL of kefir if assigned to the intervention group
* Willing to avoid kefir consumption until completion of the 26-28-week study visit if assigned to the control group
* Willing to provide required biological and clinical samples, including stool samples and glucose/insulin data, according to the study protocol
* No probiotic, prebiotic, synbiotic, or antibiotic use during the first trimester or at enrollment
* Not currently consuming probiotic, prebiotic, synbiotic, or antiobiotic supplements
* Willing to avoid probiotic, prebiotic, and synbiotic supplements until completion of the 26-28-week study visit.
* Does not engage in regular moderate-to-vigorous physical activity
* No recent or active infectious illness or significant gastrointestinal symptoms, including diarrhea or constipation in the first trimester of pregnancy.
* No history of bariatric surgery
* Able to communicate in English or French
* Currently living in Fredericton, New Brunswick, and not planning to relocate before the 1-month postpartum visit

Exclusion Criteria:

* Pre-existing metabolic disease affecting glucose regulation, including type 1 diabetes or type 2 diabetes
* Current use or first trimester use of medications known to alter glucose metabolism, such as metformin or semaglutide
* Gastrointestinal or inflammatory disease, including Crohn's disease, ulcerative colitis, celiac disease, or diagnosed irritable bowel syndrome
* Allergy, intolerance, or other contraindication to dairy or components of kefir

Where it's running

• University Of New Brunswick
  Fredericton, New Brunswick, Canada Recruiting

Study contacts

• Principal investigator: Maryam Kebbe, PhD, CLC — University of New Brunswick
• Study coordinator: Maryam Kebbe, PhD, CLC, CMSS
• Email: maryam.kebbe@unb.ca
• Phone: 15064516872

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.