Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01940835
Eligibility Criteria:
For the Diabetes Cohort:
Inclusion Criteria:
* Initial diagnosis for Type 1 Diabetes Mellitus (DM) must be within the past 6 months.
* Clinical criteria used to diagnose T1D include at least some of the following : Diabetic ketoacidosis, Polyuria, Polydipsia, weight loss, need for insulin from diagnosis, BMI less than 30, C-peptide \< 200 pmol/L or 0.6 ng/ml, Presence of Type 1 Diabetes Associated Antibodies
Exclusion Criteria:
* Subjects on antibiotics, proton pump inhibitors, aspirin, non-steroidal anti-inflammatory drugs, alcohol intake within 48 hours, a bowel preparation with 4 weeks of the studies, and smokers
* Subjects will be asked not to take any probiotics in the week before testing.
* Any known intestinal inflammation such as Gastroesophageal Reflux Disease (GERD), eosinophilic esophagitis, and inflammatory bowel disease.
* Prior gastrointestinal surgery (other than appendectomy)
* Ongoing use of antiplatelet agents or anticoagulants.
* Diabetic patients should not have a prior history of or family history of Celiac Disease (CD).
* Subjects unable to provide informed consent
* The presence of any medical or psychological condition that could interfere with the safe performance of the upper endoscopy.
* Females cannot be pregnant
For the Healthy Control Cohort:
Inclusion Criteria:
\- Healthy subjects
Exclusion Criteria:
* Controls should not have a family history of DM or CD
* Subjects on antibiotics, proton pump inhibitors, aspirin, non-steroidal anti-inflammatory drugs, alcohol intake within 48 hours, a bowel preparation with 4 weeks of the studies, and smokers
* Subjects will be asked not to take any probiotics in the week before testing.
* Any known intestinal inflammation such as Gastroesophageal Reflux Disease (GERD), eosinophilic esophagitis, and inflammatory bowel disease.
* Prior gastrointestinal surgery (other than appendectomy)
* Ongoing use of antiplatelet agents or anticoagulants.
* Subjects unable to provide informed consent
* The presence of any medical or psychological condition that could interfere with the safe performance of the upper endoscopy.
* Females cannot be pregnant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01940835
Study Brief:
Protocol Section:
NCT01940835