A Probiotic Based Intervention in Pregnancies Complicated by GDM

NCT06794723 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 6043857
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus (GDM); Microbiome, Human

Keywords

Microbiome; Gestational Diabetes; Probiotic; Glucose Control; Pregnancy

Outcome Measures

Primary Outcomes (4)

• 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.

  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: b) Mean glucose over one week of continuous glucose monitoring.

  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: 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.

  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: d) HbA1C

  38th week of pregnancy (37+0-37+6 weeks gestation)

Secondary Outcomes (14)

• Glycemic Therapy Requirements

  At Delivery

• Group B Strep

  At Delivery

• Pregnancy Outcomes - Gestational Age at Delivery

  At Delivery

• Pregnancy Outcomes - Mode of Delivery

  At Delivery

• Maternal Outcomes - Severe Maternal Morbidity

  Within 42 days of delivery

Other Outcomes (5)

• Cardiometabolic Outcomes - HbA1C

  6 Months Postpartum

• Cardiometabolic Outcomes - 2 Hour OGTT

  6 Months Postpartum

• Cardiometabolic Outcomes - Lifetime CVR Score

  6 Months Postpartum

Study Arms (2)

Probiotic

EXPERIMENTAL

The investigational product is a 5-strain probiotic plus prebiotic natural health product.

Dietary Supplement: 5-strain probiotic plus prebiotic natural health product

Placebo

PLACEBO COMPARATOR

Identically appearing placebo.

Other: Placebo

Interventions

5-strain probiotic plus prebiotic natural health product DIETARY_SUPPLEMENT

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.

Also known as: Akkermansia muciniphila (WB-STR-0001), Anaerobutyricum hallii (WB-STR-0008), Clostridium butyricum (WB-STR-006), Clostridium beijerinckii (WB-STR-0005), Bifidobacterium infantis (Dupont Danisco), chicory root inulin

Probiotic

Placebo 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.

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's University & Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Graeme N Smith, MD, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Pudwell, MPH, MSc

CONTACT

613-549-6666; jessica.pudwell@queensu.ca

Kira King, BHSc, MLT

CONTACT

613-549-6666; kira.king@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For the treatment arms, the study staff, the study participants, and the care provider will be blinded to study arm assignment and will remain blinded until 6 weeks postpartum. At the end of the 6-week visit, once all data collection for that visit is complete, participants and study staff will be unblinded to the group assignment. Participants will then be provided with the option of enrolling in the extension of the intervention until 6 months postpartum. If they consent, additional open label investigational product will be dispensed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 27, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the 5 year data retention period the study database and data dictionary will be made available in a public data archive.
• Access Criteria: Public data archive.

Locations

CA (1)