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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04275167
Eligibility Criteria:
The Inclusion Criteria:
* Children must be 6 months to 59 months old
* Adult subjects 18 years of age or older scheduled for a standard of care endoscopy
* EED manifesting as malnourishment (WHZ\<-2) without clear etiology or healthy subjects with WHZ \>=0
* Subjects and/or parents/guardians must be able to give informed consent/assent
* Subjects and/or parents/guardians must be willing to provide consent for live streaming of the procedure
* Subjects must be able to follow fasting instructions prior to the procedure
Inclusion criteria for Pregnant women:
* Subjects 18 years and older
* Subjects who are in their 2nd trimester of singleton pregnancy as confirmed by an ultrasound
* Subjects with a BMI below 18.5 without clear etiology and healthy pregnant women with BMI between 18.5 -24.5.
* Subjects must be able to follow fasting instructions prior to the procedure
* Subjects must be able to consent to the procedure
Tethered Capsule Exclusion Criteria:
* Subjects with any history of esophageal or intestinal strictures or prior GI surgery
* Subjects with history of pyloric stenosis
* Subjects with HIV diagnosis
Trans Nasal Exclusion Criteria:
* Subjects with any contraindications for NG/NJ tube placement, including but not limited to those listed below:
* Subjects with any history of esophageal or intestinal strictures or prior GI surgery
* Subjects with history of pyloric stenosis or atresia
* Subjects with suspected or diagnosed HIV, Hepatitis B and C
* Subjects with any history of esophageal or intestinal strictures or prior GI surgery
* Subjects with a history of upper gastrointestinal surgery including fundoplication
* Subjects with upper GI obstruction
* Subjects with short bowel syndrome
* Subjects with upper respiratory infection at least 7 days prior to the procedure
* Deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc.
* Patients on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
* Subjects with upper GI bleeding
Microbiome Brush Exclusion Criteria
\- Subjects with any contraindications to gastrointestinal biopsies as per standard of care
For pregnant subjects:
* Subjects with high-risk pregnancy conditions at the discretion of the subject's physician and the PI
* Pregnant subjects with a history of hyperemesis gravidarum
* Pregnant subjects with a history of severe anemia
* Pregnant subjects with gestational thrombocytopenia
* Pregnant subjects with Type 1 diabetes
* Pregnant subjects with Type 2 diabetes on medication and gestational diabetes requiring medication
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
70 Years
Study:
NCT04275167
Study Brief:
Protocol Section:
NCT04275167