Status:
COMPLETED
Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes
Lead Sponsor:
Washington University School of Medicine
Conditions:
Congenital Heart Disease
Viremia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certa...
Detailed Description
To determine prevalence in non-pregnant women (i) the investigators will perform PCR analysis of stool and blood from a prospective cohort of 225 women with diabetes (and 225 without) and sequence the...
Eligibility Criteria
Inclusion
- Exclusion Criteria - All Cohorts
- Women under the age of 18 or older than 45.
- Prediabetes defined as an HbA1C between 5.7% and 6.5% or current diagnosis of pancreatic diabetes or gestational diabetes (GDM).
- Body Mass Index greater than or equal to 35 or less than or equal to 18.
- Women unable to give informed consent and/or considered a prisoner.
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2023
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04769167
Start Date
February 1 2021
End Date
December 5 2023
Last Update
December 24 2025
Active Locations (2)
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1
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
2
St Louis Childrens Hospital
St Louis, Missouri, United States, 63110