Gestational Diabetes Mellitus (GDM)Phase 2ProbioGDMNCT06794723
A Probiotic Based Intervention in Pregnancies Complicated by GDM
A Phase 2 study testing 5-strain probiotic plus prebiotic natural health product in people with Gestational Diabetes Mellitus (GDM) and Microbiome, Human, run by Queen's University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Microbiome, Human
- What is being tested?
- 5-strain probiotic plus prebiotic natural health product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
- 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.
- Live fetus (documented positive fetal heartbeat prior to recruitment)
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- 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)
- Willing to provide fecal swab samples.
- Willing to wear a continuous glucose monitor from enrollment until delivery and for 14 days at 6 weeks postpartum.
- Willing to provide results from the continuous glucose monitor using the associated app on their mobile device.
- Willing to complete surveys related to diet, pregnancy history, and health history.
- Plan to reside in the study area at least until delivery and to deliver at Kingston Health Sciences Center (KHSC).
- Willing to test for Group B Strep during pregnancy
Who cannot join
- Any individual meeting any of the following criteria is not eligible for participation in this study:
- 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
- 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.
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- Prescription medications, especially relating to gastric function, or immunosuppressants, that, in the opinion of the investigator, might confound study results.
- Known hypersensitivity to >4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin.
- Known hypersensitivity to >4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin.
- 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.
- 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.
- Pill swallowing phobia or inability to swallow pills.
- Not taking any other probiotic supplements during the study intervention period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Queen's University & Kingston Health Sciences Centre
Kingston, Ontario, K7L2V7
Jessica Pudwell, MPH, MSc, 613-549-6666 ext. 3937, jessica.pudwell@queensu.ca
Kira King, BHSc, MLT, 613-549-6666 ext. 2740, kira.king@kingstonhsc.ca
About this study
Official title: A Single-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of a Probiotic-based Intervention to Improve Glycemic Control in Pregnancies Complicated by Gestational Diabetes.
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.
Read the detailed description
The chosen study design is a single-center, randomized, double-blind, parallel-group, placebo-controlled trial. Participants will be randomized by 2:1 to probiotic intervention or placebo. This is an exploratory study examining the impact of the intervention on glucose control among pregnant persons diagnosed with gestational diabetes.
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
- Being tested
- 5-strain probiotic plus prebiotic natural health product, Placebo
- Keywords
- Microbiome, Gestational Diabetes, Probiotic, Glucose Control, Pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-strain probiotic plus prebiotic natural health productDietary supplement
Also called Akkermansia muciniphila (WB-STR-0001), Anaerobutyricum hallii (WB-STR-0008), Clostridium butyricum (WB-STR-006), Clostridium beijerinckii (WB-STR-0005)
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | The investigational product is a 5-strain probiotic plus prebiotic natural health product. Receives: Dietary Supplement: 5-strain probiotic plus prebiotic natural health product |
| Placebo | Placebo comparator | Identically appearing placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Mean fasting glucose over one week of continuous glucose monitoring.
Measured: 38th week of pregnancy (37+0-37+6 weeks gestation)
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:
- Mean glucose over one week of continuous glucose monitoring.
Measured: 38th week of pregnancy (37+0-37+6 weeks gestation)
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:
- 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.
Measured: 38th week of pregnancy (37+0-37+6 weeks gestation)
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:
- HbA1C
Measured: 38th week of pregnancy (37+0-37+6 weeks gestation)
Secondary outcomes (14)
Glycemic Therapy Requirements
Explore whether therapy requirements such as insulin and/or metformin differ between the probiotic intervention and placebo groups.
Measured: At Delivery
Group B Strep
Explore whether the prevalence of Group B Strep in late pregnancy differs between the probiotic intervention and placebo groups.
Measured: At Delivery
Pregnancy Outcomes - Gestational Age at Delivery
Explore differences in gestational age at delivery.
Measured: At Delivery
Pregnancy Outcomes - Mode of Delivery
Explore differences in mode of delivery.
Measured: At Delivery
Maternal Outcomes - Severe Maternal Morbidity
Explore differences in severe maternal morbidity within 42 days of delivery.
Measured: Within 42 days of delivery
Maternal Outcomes - Weight Change
Explore differences in maternal weight change.
Measured: At Delivery
Neonatal Outcomes - Birthweight
Explore differences in birthweight
Measured: At delivery
Neonatal Outcomes - NICU Admissions
Explore differences in number of neontal intensive care unit admissions.
Measured: Within 28 days of delivery
Neonatal Outcomes - Hypoglycemia
Explore differences in incidence of neonatal hypoglycaemia.
Measured: Within 72 hours of delivery.
Maternal Gut Microbiome - Metagenome
To investigate if, and to what extent, the probiotic based intervention alters the gut metagenome. Sample will be collected via rectal swab for maternal participants.
Measured: 38th week of pregnancy, 6 weeks postpartum, 6 months postpartum
Maternal Gut Microbiome - Metabolome
To investigate if, and to what extent, the probiotic based intervention alters the gut metabolome. Sample will be collected via rectal swab for maternal participants.
Measured: 38th week of pregnancy, 6 weeks postpartum, 6 months postpartum
Infant Gut Microbiome - Metagenome
To investigate if, and to what extent, the probiotic based intervention alters the gut metagenome. For infant participants, swabs of stool samples will be used.
Measured: 6 Weeks of Age
Infant Gut Microbiome - Metabolome
To investigate if, and to what extent, the probiotic based intervention alters the gut metabolome. For infant participants, swabs of stool samples will be used.
Measured: 6 Weeks of Age
Safety & Side Effect Profile
To document the safety, side effect profile of the probiotic and adherence to the intervention. Specific adverse events of interest include gastrointestinal discomfort, gas, or bloating, indigestion symptoms or mild stomach upset, diarrhea, constipation, and allergic reaction.
Measured: Bi-weekly until 1 month after last dose is taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 2:1 to probiotic intervention or placebo. The randomization will be stratified by gestational age at randomization (1) Early - 25+0 to 27+6 weeks and (2) Late - 28+0 to 31+6 weeks. Randomization will be done with random block sizes of 3 and 6.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Graeme Smith, Queen's University
- Investigators
- Graeme N Smith, MD, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794723
- Sponsor's protocol ID
- 6043857
- Acronym
- ProbioGDM
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the 5 year data retention period the study database and data dictionary will be made available in a public data archive. This will likely be the Queen's University Library Research Data Archive in the Scholars Portal Dataverse. Further details will be provided as available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of a Probiotic-based Intervention to Improve Glycemic Control in Pregnancies Complicated by Gestational Diabetes.
- ClinicalTrials.gov ID
- NCT06794723
- Acronym / sponsor ID
- ProbioGDM / 6043857
- Keywords
- Microbiome, Gestational Diabetes, Probiotic, Glucose Control, Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The chosen study design is a single-center, randomized, double-blind, parallel-group, placebo-controlled trial. Participants will be randomized by 2:1 to probiotic intervention or placebo. This is an exploratory study examining the impact of the intervention on glucose control among pregnant persons diagnosed with gestational diabetes.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 2:1 to probiotic intervention or placebo. The randomization will be stratified by gestational age at randomization (1) Early - 25+0 to 27+6 weeks and (2) Late - 28+0 to 31+6 weeks. Randomization will be done with random block sizes of 3 and 6.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: 5-strain probiotic plus prebiotic natural health productThe investigational product is a 5-strain probiotic plus prebiotic natural health product. |
| Placebo | Placebo comparator | Other: PlaceboIdentically appearing placebo. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
- 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.
Key exclusion criteria (13 listed)
- Any individual meeting any of the following criteria is not eligible for participation in this study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-strain probiotic plus prebiotic natural health productAlso: Akkermansia muciniphila (WB-STR-0001), Anaerobutyricum hallii (WB-STR-0008), Clostridium butyricum (WB-STR-006), Clostridium beijerinckii (WB-STR-0005)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. | Dietary supplement | Probiotic |
| PlaceboIngredients 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 | Placebo |
Primary outcome
Glycemic Control - Mean Fasting Glucose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
14 secondary outcomes
Glycemic Therapy Requirements
Time frame: At Delivery
Group B Strep
Time frame: At Delivery
Pregnancy Outcomes - Gestational Age at Delivery
Time frame: At Delivery
Pregnancy Outcomes - Mode of Delivery
Time frame: At Delivery
Maternal Outcomes - Severe Maternal Morbidity
Time frame: Within 42 days of delivery
Maternal Outcomes - Weight Change
Time frame: At Delivery
Neonatal Outcomes - Birthweight
Time frame: At delivery
Neonatal Outcomes - NICU Admissions
Time frame: Within 28 days of delivery
Neonatal Outcomes - Hypoglycemia
Time frame: Within 72 hours of delivery.
Maternal Gut Microbiome - Metagenome
Time frame: 38th week of pregnancy, 6 weeks postpartum, 6 months postpartum
Maternal Gut Microbiome - Metabolome
Time frame: 38th week of pregnancy, 6 weeks postpartum, 6 months postpartum
Infant Gut Microbiome - Metagenome
Time frame: 6 Weeks of Age
Infant Gut Microbiome - Metabolome
Time frame: 6 Weeks of Age
Safety & Side Effect Profile
Time frame: Bi-weekly until 1 month after last dose is taken
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: Yes. After the 5 year data retention period the study database and data dictionary will be made available in a public data archive. This will likely be the Queen's University Library Research Data Archive in the Scholars Portal Dataverse. Further details will be provided as available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Graeme N Smith, MD, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-strain probiotic plus prebiotic natural health product in people with Gestational Diabetes Mellitus (GDM) and Microbiome, Human, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Pudwell, MPH, MSc (613-549-6666 ext. 3937, jessica.pudwell@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control - Mean Fasting Glucose (time frame: 38th week of pregnancy (37+0-37+6 weeks gestation)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.