A Probiotic Based Intervention in Pregnancies Complicated by GDM
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age16+
SponsorQueen's University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Participant has given written consent after study has been explained according to local regulatory requirements and before any study specific procedures.
Age ≥16 years at the time of consent.
Singleton pregnancy.
Disqualifiers
Current diagnosis of severe gestational hypertension, preeclampsia, HELLP, intrauterine growth restriction, or other clinically significant pregnancy complication(s) at the time of enrollment.
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.
Systemic antibiotic or antifungal use ≤3 months prior to enrollment.
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
Trial design
Design model
Parallel
Treatments tested in this trial
5-strain probiotic plus prebiotic natural health product
Dietary supplementThe 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
Other interventionIngredients 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.
Treatment groups
173 Participants
are divided into 2 treatment groupsGroup A: ProbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Glycemic Control - Mean Fasting Glucose
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.
Time frame
38th week of pregnancy (37+0-37+6 weeks gestation)2
Glycemic Control - Mean Glucose
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.
Time frame
38th week of pregnancy (37+0-37+6 weeks gestation)3
Glycemic Control - Time in Ranges
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.
Time frame
38th week of pregnancy (37+0-37+6 weeks gestation)4
Glycemic Control - HbA1C
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
Time frame
38th week of pregnancy (37+0-37+6 weeks gestation)Secondary outcomes
1
Glycemic Therapy Requirements
Explore whether therapy requirements such as insulin and/or metformin differ between the probiotic intervention and placebo groups.
Time frame
At Delivery2
Group B Strep
Explore whether the prevalence of Group B Strep in late pregnancy differs between the probiotic intervention and placebo groups.
Time frame
At Delivery3
Pregnancy Outcomes - Gestational Age at Delivery
Explore differences in gestational age at delivery.
Time frame
At Delivery4
Pregnancy Outcomes - Mode of Delivery
Explore differences in mode of delivery.
Time frame
At DeliveryOther outcomes
1
Cardiometabolic Outcomes - HbA1C
Compare cardiometabolic outcomes at 6 months postpartum between based on probiotic exposure in pregnancy and/or postpartum, including HbA1C.
Time frame
6 Months Postpartum2
Cardiometabolic Outcomes - 2 Hour OGTT
Compare cardiometabolic outcomes at 6 months postpartum between based on probiotic exposure in pregnancy and/or postpartum, including 2-hour oral glucose tolerance test.
Time frame
6 Months Postpartum3
Cardiometabolic Outcomes - Lifetime CVR Score
Compare cardiometabolic outcomes at 6 months postpartum between based on probiotic exposure in pregnancy and/or postpartum, including lifetime cardiovascular risk score.
Time frame
6 Months Postpartum4
Cardiometabolic Outcomes - 30 Year CVR Score
Compare cardiometabolic outcomes at 6 months postpartum between based on probiotic exposure in pregnancy and/or postpartum, including 30 Year cardiovascular risk score.
Time frame
6 Months PostpartumSponsors and contacts
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Source ClinicalTrials.gov
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