Effect of Intestinal Microecology After HDDT Combined With Probiotics for Helicobacter Pylori Eradication

H Pylori Infection Eradication Clinical Trial

Official title:

Effect of Intestinal Microecology After High Dose Dual Therapy Combined With Probiotics for Helicobacter Pylori Eradication: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292546
• Other study ID #: ZYC-Hp2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Zhongshan Hospital (Xiamen), Fudan University
• Contact: Keng Li, Master
• Phone: 86-592-3501990
• Email: li.keng[@]zsxmhospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the effect of Intestinal microecology after high dose dual therapy combined with probiotics for Helicobacter pylori eradication

Description:

The combination of vonoprazan (VPZ) and amoxicillin (VA therapy) has been shown to achieve notable eradication rates for Helicobacter pylori (H. pylori). Patients who receive this treatment are prone to adverse reactions, such as diarrhea, abdominal distention. We plan to combine probiotic therapy with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age from 18 to 65 years;
• H.pylori infection diagnosed by 13C-urea breath test;
• no history of H. pylori eradication.

Exclusion Criteria:

• allergy to amoxicillin;
• Zollinger-Ellison syndrome, GC,upper gastrointestinal bleeding, or active peptic ulcer;
• coexistence of significant concomitant illnesses, including heart disease, renal failure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;
• use of PPI and antibiotics within the previous one month;
• unwillingness to participate in this study.

Related Conditions & MeSH terms

• H Pylori Infection Eradication

Intervention

Drug:
• Vonorason
Group A: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: Vonorason 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
• Amoxicillin
Group A: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: Vonorason 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
• Bacillus subtilis enteric-coated capsules
Group A: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: Vonorason 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Hospital (Xiamen), Fudan University

References & Publications (1)

Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Shu X, Xie Y, Lu NH, Zhu Y. Altered Gut Microbiota and Short-Chain Fatty Acids After Vonoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication. Front Cell Infect Microbiol. 2022 Jun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiota	Diversity and Compositional Analysis of Gut Microbiota is tested by DNA Extraction and 16S rRNA Gene Amplification.	44 days
Secondary	Fecal metabolites	Diversity and Compositional Analysis of Fecal metabolites is tested by Purification and Gas Chromatography-Mass Spectrometry Analysis of Short-Chain Fatty Acids.	44 days
Secondary	Eradication rate	Eradication rate of H pylori, presenting with negative results on the 13C-UBT test	44 days
Secondary	Frequency of the adverse events	Incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.	44 days
Secondary	Compliance rate of the drugs	Compliance is defined as good when they had taken more than 80% of the total medication.	44 days