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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT03789461
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75; and
2. BMI ≥28 kg/m\^2 and \< 45 kg/m\^2; and
3. Written informed consent obtained
Exclusion Criteria:
1. Current pregnancy
2. Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer)
3. Known history or concomitant significant food allergies
4. Immunosuppressed subjects
5. Known history of severe organ failure (including decompensated cirrhosis), kidney failure, epilepsy, acquired immunodeficiency syndrome
6. Current active sepsis
7. Known contraindications to oesophago-gastro-duodenoscopy (OGD)
8. Use of probiotic or antibiotics in recent 3 months
9. New drugs in the last three months that can impact on metabolism or body weight
10. Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, ileoectomy, colectomy
11. Patients who have a confirmed current active malignancy or cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03789461
Study Brief:
Protocol Section:
NCT03789461