Evaluate the Intestinal Microbiome in Patients With Erosive Gastroesophageal Reflux Disease and i… (NCT04248296) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Intestinal Microbiome in Patients With Erosive Gastroesophageal Reflux Disease and in Asymptomatic Healthy Controls
Brazil22 participantsStarted 2017-05-10
Plain-language summary
. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* a confirmed diagnosis of erosive GERD through clinical and endoscopic criteria
* who have not taken omeprazole or any other drug that changes gastric pH in the thirty days prior to the completion of diagnostic tests for GERD and other tests included in the protocol.
Exclusion Criteria:
* Use of antimicrobials or probiotics in the last three months
* Presence of severe and/or extensive atrophic gastritis confirmed histologically
* Comorbidities that could interfere with motility of the gastrointestinal tract (diabetes mellitus, previous stroke, neurological diseases)
* Use of drugs that could interfere with motility of the gastrointestinal tract or salivation (calcium channel blockers, nitrates, anticholinergics, estrogens)
* Bulky hiatal hernia (greater than or equal to 5 cm)
* Los Angeles grade C or D erosive esophagitis
* Long-distance travel in the last 3 months (outside the southeastern region of the country)
* Pregnant or breastfeeding patients
* Previous history of upper digestive tract surgery
* Obesity (body mass index equal to or greater than 30 kg / m2)
* Patient with a consumptive syndrome or malnutrition
* Tobacco use in the last 30 days / Alcohol use (more than 20 g per day, in the last 30 days)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.