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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT01154569
Eligibility Criteria:
Inclusion Criteria:
1. Male and Female
2. 18 - 60 years old
3. ≥ 3 months post-RYGB surgery or a suitable control for bariatric surgery
4. Able to provide written informed consent.
Exclusion Criteria:
1. Undergone or undergoing reversal of a previous bariatric procedure which involves further resection or bypass of the intestine.
2. Any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting
3. Currently on azithromycin therapy
4. Any contraindications to azithromycin therapy such as:
* Allergy or hypersensitivity to the drug
* liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal
* end-stage renal failure (glomerular filtration rate \< 10 ml/min)
* macrolide hypersensitivity
* history of torsade de pointes or baseline QTc interval ≥ 500 ms
* acute illness
5. Pregnant or nursing
6. Concomitant treatment with septra, anti-HIV drugs, digoxin, disopyramide, ergotamine, dihydroergotamine, triazolam, antihistamines (terfenadine, astemizole) and theophylline is also a contraindication to enrolment because of the potential for drug interactions that would affect the blood concentrations of azithromycin or these agents.
7. Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01154569
Study Brief:
Protocol Section:
NCT01154569