Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes
NCT ID: NCT04769167
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2021-02-01
2023-12-05
Brief Summary
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The investigator's goal is to answer the above gaps in knowledge. The investigators propose to do that using two different approaches; one retrospective (analysis of samples in two existing, large biorepositories) and the other prospective. The investigator's have created a multi-disciplinary team to bring together the needed expertise from individuals who have overlapping and vested interest in this project.
The investigator's specific aim is to examine the diversity of the gut virome in non-pregnant and pregnant women with and without diabetes, with special emphasis on known cardiotropic viruses (those with tropism for cardiac tissues). This study is seen by the investigator's as the first step prior to a larger prospective multi-institutional study to specifically assess the linkage between the maternal virome and CHD pathogenesis.
Detailed Description
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The investigators will also perform a comprehensive virome analysis using metagenomic shotgun sequencing with ViroCap enrichment, a method developed by co-PI, on 1st trimester stool samples from a subset (\~4-500) of women (both EVB positive and negative) enrolled in Aim 1. The investigators will complement this data with VirScan® analysis of blood collected from the same women at 1st and 2nd/3rd trimester. VirScan® is a revolutionary new technique for comprehensive profiling of sera for antibodies against \~400 species and strains of pathogenic viruses.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
SCREENING
SINGLE
Study Groups
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Healthy Non Pregnant Women (HNPW)
HNPW are healthy women and not pregnant
Stool and Blood Specimen Collection
Stool and Blood specimens will be collected at 3 designated time points
Follow-up Medical Record Review
Participant medical records as well as the medical records of infants during study enrollment will be reviewed up to 3 years from the date of enrollment.
Diabetic Non Pregnant Women (DNPW)
DNPW are diabetic and not pregnant
Stool and Blood Specimen Collection
Stool and Blood specimens will be collected at 3 designated time points
Follow-up Medical Record Review
Participant medical records as well as the medical records of infants during study enrollment will be reviewed up to 3 years from the date of enrollment.
Healthy Pregnant Women (HPW)
HNPW are healthy women and currently pregnant
Stool and Blood Specimen Collection
Stool and Blood specimens will be collected at 3 designated time points
Follow-up Medical Record Review
Participant medical records as well as the medical records of infants during study enrollment will be reviewed up to 3 years from the date of enrollment.
Diabetic Pregnant Women (DPW)
DNPW are diabetic and currently pregnant
Stool and Blood Specimen Collection
Stool and Blood specimens will be collected at 3 designated time points
Follow-up Medical Record Review
Participant medical records as well as the medical records of infants during study enrollment will be reviewed up to 3 years from the date of enrollment.
Interventions
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Stool and Blood Specimen Collection
Stool and Blood specimens will be collected at 3 designated time points
Follow-up Medical Record Review
Participant medical records as well as the medical records of infants during study enrollment will be reviewed up to 3 years from the date of enrollment.
Eligibility Criteria
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Exclusion Criteria
2. Prediabetes defined as an HbA1C between 5.7% and 6.5% or current diagnosis of pancreatic diabetes or gestational diabetes (GDM).
3. Body Mass Index greater than or equal to 35 or less than or equal to 18.
4. Women unable to give informed consent and/or considered a prisoner.
5. Use of any of the following drugs within the last 6 months:
5a.Systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); 5b.Cytokines; 5c. Immunomodulators or immunosuppressive cytotoxic agents; 5d. Large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
6\. A positive test for HIV, HBV or HCV or any confirmed or suspected condition/state of immunosuppression or immunodeficiency.
7\. History of autoimmune disorders other than T1D or treated thyroid disease.
8\. Major surgery of the GI tract, except for cholecystectomy and appendectomy, in the past five years.
9\. Any major bowel resection at any time.
10\. History of active uncontrolled gastrointestinal disorders or diseases including: 10a. Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), 10b. Crohn's disease (mild-moderate-severe), or indeterminate colitis; 10c. Irritable bowel syndrome (IBS) (moderate-severe); 10d. Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).
11\. Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
12\. Use of assisted reproductive technology (ART)including but not limited to In vitro Fertilization (IVF), Gamete intrafallopian transfer (GIFT) and Zygote intrafallopian transfer (ZIFT).
13\. Any other condition which, in the opinion of the investigators, renders the patient unfit for study participation and procedures.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Pirooz Eghtesady, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty
Locations
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Barnes Jewish Hospital
St Louis, Missouri, United States
St Louis Childrens Hospital
St Louis, Missouri, United States
Countries
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Other Identifiers
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202002043
Identifier Type: -
Identifier Source: org_study_id