Gestational DiabetesNCT04420507
Gut and Oral Microbiome of GDM Patients During Pregnancy
An observational study of Gestational Diabetes and Pregnancy Related, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The study aimed to clarify the characteristics of the intestinal and oral microbiome of Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the relationship between the microbiome and GDM. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Pregnancy Related
- How many people
- 163 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2017to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women who can ensure a regular prenatal check in the PUMCH OB clinic.
Who may be able to join
- pregnant women
- gestational age: before 13+6 weeks
- regular prenatal care in PUMCH
Who cannot join
- have medical history or current conditions： Gastrointestinal disorders, for example: Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or other severe CTD;
- pregnant, combine with malignancy diseases;
- pregnant, can't ensure regular prenatal check.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Different Characteristics of Gut and Oral Microbiota of Women With Gestational Diabetes Mellitus
The study aimed to clarify the characteristics of the intestinal and oral microbiome of Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the relationship between the microbiome and GDM.
Read the detailed description
The aims of the study are to reveal the possibly natural change of the gut and oral microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational weeks）and following the pregnancies till delivery. The stool samples and saliva samples of the recruits will be collected in 9~14,24~28 and 32~37 gestational weeks separately. The investigators will also perform oral examination between 24~28 weeks and sample subgingival plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to analyze microbiome. And part of the samples of GDM patients will be analyzed using metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome between GDM patients and healthy women will be expected, as well as the natural change during pregnancy.
- Conditions
- Gestational Diabetes, Pregnancy Related
- Keywords
- Gastrointestinal Microbiome, pregnancy, gestational diabetes mellitus
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GDM group | pregnant women who are diagnosed after 75g OGTT test between 24~27+6 gestational weeks | |
| health group | pregnant women who pass the 75g OGTT test and aren't diagnosed as GDM, and also don't have any other conditions, like hypertensive disorders, IBD, gastrointestinal ulcer, and so on. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the gut and oral microbiome of GDM patients during pregnancy
The composition and species of gut and oral microbiome of GDM patients,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
Measured: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
the gut and oral microbiome of healthy pregnant women
The composition and species of gut and oral microbiome of healthy pregnant women ,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
Measured: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
Secondary outcomes (1)
The glucose level during pregnancy
The fasting blood glucose level and the glycosylated albumin level in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). And the result of 75gOGTT test.
Measured: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 May 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420507
- Sponsor's protocol ID
- Gut and oral microbiome of GDM
- Status last verified
- Mar 2020
- First submitted
- 10 Sep 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edwards SM, Cunningham SA, Dunlop AL, Corwin EJ. The Maternal Gut Microbiome During Pregnancy. MCN Am J Matern Child Nurs. 2017 Nov/Dec;42(6):310-317. doi: 10.1097/NMC.0000000000000372.
PubMed 28787280Walker RW, Clemente JC, Peter I, Loos RJF. The prenatal gut microbiome: are we colonized with bacteria in utero? Pediatr Obes. 2017 Aug;12 Suppl 1(Suppl 1):3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26.
PubMed 28447406Jordan S, Baker B, Dunn A, Edwards S, Ferranti E, Mutic AD, Yang I, Rodriguez J. Maternal-Child Microbiome: Specimen Collection, Storage, and Implications for Research and Practice. Nurs Res. 2017 Mar/Apr;66(2):175-183. doi: 10.1097/NNR.0000000000000201.
PubMed 28252577Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027.
PubMed 27814521
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Characteristics of Gut and Oral Microbiota of Women With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04420507
- Acronym / sponsor ID
- Gut and oral microbiome of GDM
- Conditions
- Gestational Diabetes, Pregnancy Related
- Keywords
- Gastrointestinal Microbiome, pregnancy, gestational diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 9 Jun 2020 (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.
The study aimed to clarify the characteristics of the intestinal and oral microbiome of Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the relationship between the microbiome and GDM.
Detailed description
The aims of the study are to reveal the possibly natural change of the gut and oral microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational weeks）and following the pregnancies till delivery. The stool samples and saliva samples of the recruits will be collected in 9~14,24~28 and 32~37 gestational weeks separately. The investigators will also perform oral examination between 24~28 weeks and sample subgingival plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to analyze microbiome. And part of the samples of GDM patients will be analyzed using metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome between GDM patients and healthy women will be expected, as well as the natural change during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM group | – | –pregnant women who are diagnosed after 75g OGTT test between 24~27+6 gestational weeks |
| health group | – | –pregnant women who pass the 75g OGTT test and aren't diagnosed as GDM, and also don't have any other conditions, like hypertensive disorders, IBD, gastrointestinal ulcer, and so on. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women who can ensure a regular prenatal check in the PUMCH OB clinic.
Key inclusion criteria (3 listed)
- pregnant women
- gestational age: before 13+6 weeks
- regular prenatal care in PUMCH
Key exclusion criteria (3 listed)
- have medical history or current conditions： Gastrointestinal disorders, for example: Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or other severe CTD;
- pregnant, combine with malignancy diseases;
- pregnant, can't ensure regular prenatal check.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the gut and oral microbiome of GDM patients during pregnancy
Time frame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
The composition and species of gut and oral microbiome of GDM patients,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
the gut and oral microbiome of healthy pregnant women
Time frame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
The composition and species of gut and oral microbiome of healthy pregnant women ,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
1 secondary outcome
The glucose level during pregnancy
Time frame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Results publication: PubMed 28787280Edwards SM, Cunningham SA, Dunlop AL, Corwin EJ. The Maternal Gut Microbiome During Pregnancy. MCN Am J Matern Child Nurs. 2017 Nov/Dec;42(6):310-317. doi: 10.1097/NMC.0000000000000372.
- Results publication: PubMed 28447406Walker RW, Clemente JC, Peter I, Loos RJF. The prenatal gut microbiome: are we colonized with bacteria in utero? Pediatr Obes. 2017 Aug;12 Suppl 1(Suppl 1):3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26.
- Results publication: PubMed 28252577Jordan S, Baker B, Dunn A, Edwards S, Ferranti E, Mutic AD, Yang I, Rodriguez J. Maternal-Child Microbiome: Specimen Collection, Storage, and Implications for Research and Practice. Nurs Res. 2017 Mar/Apr;66(2):175-183. doi: 10.1097/NNR.0000000000000201.
- Results publication: PubMed 27814521Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Pregnancy Related, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jun 2020. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the gut and oral microbiome of GDM patients during pregnancy (time frame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420507, which also lists 4 linked publications.
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 9 Jun 2020.