UnknownPhase 1/2

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 range18 Years – 70 Years

SexALL

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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;
✕. 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;

What they're measuring

compare eradication rates of the two groups by 13C-UBT

Timeframe: 6 weeks

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials