[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645319":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":18,"responsibleParty":34,"collaborators":18,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":18,"enrollmentInfo":48,"targetDuration":18,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":18},{"fullName":5,"class":6},"University of New Brunswick","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Daily Kefir Intake","EXPERIMENTAL","Participants assigned to this group will consume 250 mL of kefir daily beginning at approximately 14 weeks' gestation through the routine GDM screening window at 26-28 weeks' gestation. Participants will otherwise continue their usual prenatal care and habitual diet.",[13],"Dietary Supplement: Kefir",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Participants assigned to this group will continue their usual prenatal care and habitual diet beginning at approximately 14 weeks' gestation through the routine GDM screening window at 26-28 weeks' gestation. Participants will not consume the study kefir.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","Kefir","Kefir is a fermented dairy beverage containing a complex host of live bacteria and yeasts. In this study, participants assigned to the intervention group will consume 250 mL of kefir daily from approximately 14 weeks' gestation until the routine GDM screening window at 26-28 weeks' gestation. Participants will otherwise continue their usual prenatal care and habitual diet.",[9],[26],{"name":27,"affiliation":5,"role":28},"Maryam Kebbe, PhD, CLC","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","15064516872","maryam.kebbe@unb.ca",{"type":28,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Maryam Kebbe","Associate Professor","100645319","diabetes-insulin-gut-enteric-supplementation-trial-100645319",false,"NCT07682077","Diabetes, Insulin, Gut, Enteric Supplementation Trial","Effects of a Kefir Intervention in Pregnancy on Glucose, Insulin, Gestational Diabetes Mellitus, and the Gut Microbiome and Metabolites: A Randomized Controlled Trial","DIGEST","Inclusion Criteria:\n\n* Pregnant individual with a singleton pregnancy\n* 19 years and older of age\n* Gestational age 14,3 weeks or less at enrolment\n* 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\n* Willing and able to comply with study group assignment, including daily consumption of 250 mL of kefir if assigned to the intervention group\n* Willing to avoid kefir consumption until completion of the 26-28-week study visit if assigned to the control group\n* Willing to provide required biological and clinical samples, including stool samples and glucose\u002Finsulin data, according to the study protocol\n* No probiotic, prebiotic, synbiotic, or antibiotic use during the first trimester or at enrollment\n* Not currently consuming probiotic, prebiotic, synbiotic, or antiobiotic supplements\n* Willing to avoid probiotic, prebiotic, and synbiotic supplements until completion of the 26-28-week study visit.\n* Does not engage in regular moderate-to-vigorous physical activity\n* No recent or active infectious illness or significant gastrointestinal symptoms, including diarrhea or constipation in the first trimester of pregnancy.\n* No history of bariatric surgery\n* Able to communicate in English or French\n* Currently living in Fredericton, New Brunswick, and not planning to relocate before the 1-month postpartum visit\n\nExclusion Criteria:\n\n* Pre-existing metabolic disease affecting glucose regulation, including type 1 diabetes or type 2 diabetes\n* Current use or first trimester use of medications known to alter glucose metabolism, such as metformin or semaglutide\n* Gastrointestinal or inflammatory disease, including Crohn's disease, ulcerative colitis, celiac disease, or diagnosed irritable bowel syndrome\n* Allergy, intolerance, or other contraindication to dairy or components of kefir",true,"FEMALE","19 Years",{"count":49,"type":50},60,"ESTIMATED","INTERVENTIONAL",[53],"NA","Pregnancy is a critical window for metabolic health, and early changes in blood sugar regulation can increase the risk of gestational diabetes mellitus (GDM), which affects both maternal and infant health. At the same time, the maternal gut microbiome changes throughout pregnancy and may play a role in glucose metabolism and insulin resistance. Kefir, a fermented milk drink containing beneficial bacteria and yeasts, may be a simple dietary strategy to support metabolic health during pregnancy, but its role in preventing GDM has not been well studied.\n\nThis study will test whether drinking kefir daily from mid-pregnancy until routine GDM screening can improve glucose and insulin regulation, reduce the incidence of GDM, and modulate the maternal gut microbiome and metabolites, among other outcomes.\n\nPregnant individuals will be randomly assigned to either a kefir group or a control group receiving usual prenatal care. Researchers will collect blood glucose and insulin measures, dietary information, stool samples, and body composition data across pregnancy and postpartum to evaluate metabolic and microbiome-related changes.\n\nAs one of the first studies to examine kefir as an early pregnancy intervention for GDM prevention, this study will help clarify whether a practical, food-based approach can improve maternal metabolic health. The findings may support future nutrition strategies aimed at reducing GDM risk and improving pregnancy outcomes.",[56,57,58,59,60],"Gestational Diabetes Mellitus (GDM)","Blood Glucose","Insulin Resistance, Diabetes","Gut Microbiome","Gut Metabolites",[62,63,64,22,65,66,67,68],"Gestational diabetes mellitus","Pregnancy","Probiotics","Gut microbiome","Gut metabolites","Glucose","Insulin","NOT_YET_RECRUITING","2026-06-30",{"date":72,"type":73},"2026-07-02","ACTUAL",{"date":75,"type":50},"2026-06-01",{"date":77,"type":50},"2029-06-01",{"name":5,"class":6}]