A Probiotic Based Intervention in Pregnancies Complicated by GDM

Launched by QUEEN'S UNIVERSITY · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a special probiotic supplement might help women who have gestational diabetes, a type of diabetes that can develop during pregnancy. The researchers want to see if taking these probiotics can improve blood sugar control and change the gut bacteria in a healthier way. The study will involve about 115 pregnant women between 24 and 31 weeks of pregnancy who have been diagnosed with gestational diabetes. Participants will be randomly assigned to either receive the probiotics or a placebo (a non-active treatment) for six weeks after giving birth. After this period, they will have the option to continue with the probiotics for an additional six months.

To be eligible for this trial, women must be at least 16 years old, be having a single baby, and have a confirmed diagnosis of gestational diabetes. They should also be willing to provide stool samples and wear a continuous glucose monitor to track their blood sugar levels. However, those with certain medical conditions or who are using specific medications might not be able to participate. This study is not yet recruiting participants, so interested individuals will need to wait for the study to begin.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
• • 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• • 2. Participant has given written consent after study has been explained according to local regulatory requirements and before any study specific procedures.
• • 3. Age ≥16 years at the time of consent.
• • 4. Singleton pregnancy.
• • 5. Live fetus (documented positive fetal heartbeat prior to recruitment)
• • 6. Diagnosis of Gestational Diabetes (GDM) at the time of inclusion (documented 50g glucose challenge test (\>11.1 mmol/L) and/or 75g oral glucose tolerance test with results exceeding the normal range (fasting \>5.3 mmol/L, 1 hour \>10.6 mmol/L, or 2 hour \> 8.9 mmol/L)
• • 7. Willing to provide fecal swab samples.
• • 8. Willing to wear a continuous glucose monitor from enrollment until delivery and for 14 days at 6 weeks postpartum.
• • 9. Willing to provide results from the continuous glucose monitor using the associated app on their mobile device.
• • 10. Willing to complete surveys related to diet, pregnancy history, and health history.
• • 11. Plan to reside in the study area at least until delivery and to deliver at Kingston Health Sciences Center (KHSC).
• • 12. Willing to test for Group B Strep during pregnancy
• Exclusion Criteria:
• Any individual meeting any of the following criteria is not eligible for participation in this study:
• • 1. Current diagnosis of severe gestational hypertension, preeclampsia, HELLP, intrauterine growth restriction, or other clinically significant pregnancy complication(s) at the time of enrollment.
• • 2. Sustained use of substances, such as alcohol, cannabis, nicotine, and other recreational drugs. This is defined as any use after the patient is aware that they are pregnant OR as per the discretion of the investigator.
• • 3. Systemic antibiotic or antifungal use ≤3 months prior to enrollment.
• • 4. Active clinical infection(s), such as sexually transmitted infections, urinary tract infectionss, systemic infections, periodontal disease or positive blood cultures ≤3 months prior to enrollment
• • 5. Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities, such as autoimmune disease, inflammatory bowel disease (IBD), Crohn's, colitis, or other conditions, that, in the opinion of the investigator, might confound study results.
• • 6. Prescription medications, especially relating to gastric function, or immunosuppressants, that, in the opinion of the investigator, might confound study results.
• • 7. Known hypersensitivity to \>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin.
• • 8. Known hypersensitivity to \>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin.
• • 9. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of prenatal care, such as behavioural or cognitive impairment or neuropsychiatric illness.
• • 10. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
• • 11. Pill swallowing phobia or inability to swallow pills.
• • 12. Not taking any other probiotic supplements during the study intervention period.