Fucoidan Assisted Eradication of Helicobacter Pylori
China60 participantsStarted 2022-10-01
Plain-language summary
The purpose of this study is to investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients.
Who can participate
Age range
18 Years – 70 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
. Age 18-65 years old;
. Patients diagnosed as HP positive;
. Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year;
. Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
. Allergic to the study drug (penicillin allergy, etc.);
. Patients with chronic gastritis and peptic ulcer;
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.
What they're measuring
1
compare eradication rates of the two groups by 13C-UBT
Timeframe: 6 weeks
2
Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing
Timeframe: 6 weeks
Trial details
NCT IDNCT05461508
SponsorNanjing First Hospital, Nanjing Medical University
. Patients who have received HP eradication treatment within half a year;
. Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment;
. Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants;
. History of esophageal or gastric surgery;
. Pregnant and lactating women;
. Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;