The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

The Effect of Probiotics With Vonoprazan-amoxicillin Dual Therapy on Gut Microbiotain After Helicobacter Pylori Eradication: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05658055
• Other study ID #: KY20221124-08
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Zhenyu Zhang
• Phone: +86 025-87726248
• Email: zzy6565[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Pylori Infection
• Infections
• Intestinal Bacteria Flora Disturbance

Intervention

Drug:
• Vonoprazan
Potassium-competitive acid blocker
• Amoxicillin
Antibiotic for H. pylori eradication
• probiotics
Medilac-S; Enterococcus faecium 4.5*10^8 and Bacillus subtilis 5.0*10^7, Hanmi,Beijing, China

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The comparison of the gut microbiota composition	Stool samples were collected at the points of before eradication, after eradication and at confirmation. The gut microbiota composition of individuals was analyzed by 16S rRNA gene sequencing. Microbiome bioinformatics were performed with QIIME2 and R packages.	12mouth
Secondary	Helicobacter pylori eradication rate	Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.	four to six weeks after completion of the medication
Secondary	Adverse event	adverse events are recorded by the patient	one week after completion of the medication