A Probiotic Based Intervention in Pregnancies Complicated by GDM
NCT ID: NCT06794723
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
173 participants
INTERVENTIONAL
2025-10-01
2029-12-31
Brief Summary
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Detailed Description
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Participants may be enrolled and randomized after diagnosis of GDM between 240 and 316 weeks gestation. Participants will stop taking the intervention at 6 weeks postpartum. At this time, they will be unblinded and offered the option of participating in an open-label extension of the intervention until 6 months postpartum.
Participants will be seen for up to 4 study visits: 3 mandatory visits in the main study and 1 in the optional extension. Brief visit outlines are below.
Visit 1 at 24-31 weeks gestation:
* eligibility confirmation
* consent
* randomization
* weight, height, blood pressure, method of glucose control from chart
* dispense investigational product
* baseline survey
* pregnancy history questionnaire
* Diet Screening for Adults in Canada (D-SAC)
* Automated Self-Administered 24-Hour Dietary Recall (ASA) x2
* Libre2 1 week of monitoring data
* concommitant medication log
* maternal rectal swab
Visit 2 at 37 weeks gestation:
* weight, height, blood pressure, method of glucose control from chart
* dispense and reconcile investigational product
* D-SAC
* ASA x2
* Libre2 1 week of monitoring data
* concommitant medication log
* maternal rectal swab
* adverse event log
Delivery:
* infant consent
* weight, height, blood pressure, method of glucose control from chart
* delivery chart review
* Libre2 1 week of monitoring data
* weigh placenta
* concommitant medication log
* adverse event log
Visit 3 at 6 weeks postpartum:
* reconcile investigational product
* unblind
* postpartum survey
* D-SAC
* ASA x2
* concommitant medication log
* maternal rectal swab
* infant fecal swab
* adverse event log
* study completion form
Optional Open Label Extension - At 6 weeks postpartum, once all study components are complete, participants will be unblinded and invited to participate in an open label, single arm extension of the intervention till 6 months postpartum. Participants who agree to participate in the extension of the intervention will be provided with additional open-label product until 6 months postpartum.
Visit E1 (open label extension, visit done with V3)
* enroll in extension if desired
* dispense open label product
* maternal and infant consent
Visit E2 at 6 months postpartum:
* Chart review
* D-SAC
* ASA x2
* concommitant medication log
* maternal rectal swab
* infant fecal swab
* adverse event log
* study completion form
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic
The investigational product is a 5-strain probiotic plus prebiotic natural health product.
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.
Placebo
Identically appearing placebo.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
FEMALE
No
Sponsors
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Queen's University
OTHER
Responsible Party
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Dr. Graeme Smith
Professor
Principal Investigators
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Graeme N Smith, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Queen's University & Kingston Health Sciences Centre
Kingston, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6043857
Identifier Type: -
Identifier Source: org_study_id
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