Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes (CHARMED)
Congenital Heart Disease, Viremia, Virus Diseases
About this trial
This is an interventional screening trial for Congenital Heart Disease
Eligibility Criteria
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.
Sites / Locations
- Barnes Jewish HospitalRecruiting
- St Louis Childrens HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Healthy Non Pregnant Women (HNPW)
Diabetic Non Pregnant Women (DNPW)
Healthy Pregnant Women (HPW)
Diabetic Pregnant Women (DPW)
HNPW are healthy women and not pregnant
DNPW are diabetic and not pregnant
HNPW are healthy women and currently pregnant
DNPW are diabetic and currently pregnant