SweMaMi DMI, Microbiome | NCT04346524

Studies
SweMaMi DMI, Microbiome

NCT04346524

Sponsor

Karolinska Institutet

Status

Unknown status

Last Update Posted

Nov 23, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Type 1 Diabetes

Interventions

sampling of microbiome

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Apr 9, 2020

First Submission Date that Met QC Criteria

Apr 11, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2021

Last Update Posted Date

Nov 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eva Wiberg-Itzel, Associate professor, Karolinska InstitutetPrincipal Investigator

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Dysbiosis is associated with an increased risk of preeclampsia during pregnancy. The microbiome differs between those with and without type 1 diabetes and the cause of type 1 diabetes has been associated with dysbiosis. Increased knowledge of the microbiome and its variation, depending on the state of health during pregnancies complicated with type 1 diabetes, could in the future lead to preventive care and treatments during these pregnancies.

Detailed Description

Prospective cohort. All women with type 1 diabetes that are planning a pregnancy and being cared for at the diabetic ward at Södersjukhuset will be asked to participate, n= 55.

All pregnancies complicated with type 1 diabetes that are being cared for at the special maternity ward at Södersjukhuset, n=45.

The expected to include is 100. Expected viable pregnancies: 50.

The maternal vaginal, fecal and oral microbiome will be sampled by "self-sampling" at home before, during and after the pregnancy, by this schedule:

Inclusion, before pregnancy after an appointment with the diabetic doctor or nurse. Or at the first visit at the special maternity care ward during pregnancy (around gestational week 8).
When the pregnancy is first discovered if the inclusion were before pregnancy.
Week 28.
When attending delivery ward in labor
6-10 weeks postpartum from both the mother and the new-born. The tests will be sent to the obstetric research center at Södersjukhuset, where the tests will be saved in freezes. The analysis will be performed at CTMR at the Karolinska Institute.

Background, pregnancy and delivery data will then be associated with the woman microbiome in the vagina, in feces and in saliva.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
microbiome sampling		pregnant women with type 1 diabetes	Other: sampling of microbiome

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sampling of microbiome	Other	women will sample from vagina, feces, and saliva during pregnancy	microbiome sampling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal complications during pregnancy	The frequency of Preeklampsia, hypertension and other pregnancy complications	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Fetal complications during pregnancy	Large for gestational age	through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant Women with type 1 diabetes
Included as a patient at women's clinic Soderhospital in Stockholm
Acceptant to sample her microbiome during pregnancy

Exclusion Criteria:

Women without type 1 diabetes

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women with type 1 diabetes

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

pregnant women with type 1 diabetes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eva Wiberg-Itzel, PhD	Contact	+46708775346		eva.itzel@telia.com

Overall Officials

Name	Affiliation	Role
Eva Wiberg-Itzel, PhD	Karolinska Institute Sodersjukhuset Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eva Wiberg-Itzel	Not yet recruiting	Danderyd	Sverige	18239	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We have not discussed this question yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided