Starting soon
Phase 2
A Probiotic Based Intervention in Pregnancies Complicated by GDM
Condition(s) studied
Gestational Diabetes Mellitus (GDM)Microbiome, Human
Investigational drug(s) / intervention(s)
5-strain probiotic plus prebiotic natural health productPlacebo
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.
Study summary
This study is a single center randomized control trial of a probiotic based intervention in pregnancies complicated by gestational diabetes. A healthy gut microbiome is now recognized as a key component of human health and dysbiosis of the gut microbiome, including lack of diversity, is believed to contribute to the development of many diseases and alter glucose control. The study aims to explore whether this probiotic intervention will improve glucose control and change the gut microbiome. Participants may be enrolled and randomized after diagnosis of gestational diabetes between 24 and 31 weeks gestation. 115 participants will be randomized in a ratio of 2 in the probiotic intervention group to 1 in the placebo group. 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.
Eligibility
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.
Primary outcome measure(s)
- Glycemic Control - Mean Fasting Glucose — 38th week of pregnancy (37+0-37+6 weeks gestation)
To assess the impact that the probiotic based intervention has on glycemic control during pregnancy. Measured using continuous glucose monitoring comparing the week after randomization to the 38th week of pregnancy (37+0-37+6).
Assessed based on:
a) Mean fasting glucose over one week of continuous glucose monitoring.
- Glycemic Control - Mean Glucose — 38th week of pregnancy (37+0-37+6 weeks gestation)
To assess the impact that the probiotic based intervention has on glycemic control during pregnancy. Measured using continuous glucose monitoring comparing the week after randomization to the 38th week of pregnancy (37+0-37+6).
Assessed based on:
b) Mean glucose over one week of continuous glucose monitoring.
- Glycemic Control - Time in Ranges — 38th week of pregnancy (37+0-37+6 weeks gestation)
To assess the impact that the probiotic based intervention has on glycemic control during pregnancy. Measured using continuous glucose monitoring comparing the week after randomization to the 38th week of pregnancy (37+0-37+6).
Assessed based on:
c) Proportion of time in range (3.9-10.0 mmol/L), hypoglycemia (\<3.9 mmol/L), severe hypoglycemia (\<3.0 mmol/L), hyperglycemia (\>10.0 mmol/L) and severe hyperglycemia (\>13.9 mmol/L) over one week of continuous glucose monitoring.
- Glycemic Control - HbA1C — 38th week of pregnancy (37+0-37+6 weeks gestation)
To assess the impact that the probiotic based intervention has on glycemic control during pregnancy. Measured using continuous glucose monitoring comparing the week after randomization to the 38th week of pregnancy (37+0-37+6).
Assessed based on:
d) HbA1C
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Queen's University & Kingston Health Sciences Centre |
Kingston |
Ontario |
|
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