The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Helicobacter Pylori Infection; Intestinal Bacteria Flora Disturbance; Infections

Treatments: Drug: Amoxicillin; Drug: probiotics; Drug: Vonoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT05658055

KY20221124-08

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics

Full description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 100 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg tid, Probiotics 3tabltes tid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days. On the 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 42th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages between 18 and 65 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion criteria

1. allergic reactions to the study drugs;
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Amoxicillin combined with vonoprazan

Active Comparator group

Description:

The subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin

Probiotics combined with vonoprazan and amoxicillin

Experimental group

Description:

The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and probiotics three times a day. These three drugs were taken continuously for 14 days.

Treatment:

Drug: probiotics

Drug: Vonoprazan

Drug: Amoxicillin