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
Qualifiers
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
Treatments tested in this trial
- 5-strain probiotic plus prebiotic natural health product
- Placebo
Treatment groups
173 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov