Clinical trial NCT06292546: The Effects of High-dose Dual Therapy With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment
Official title: The Effects of High-dose Dual Therapy Combined With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Metabolic Disturbance
Helicobacter Pylori Eradication
Keywords: Helicobacter pylori
Eradication
Vonoprazan
Amoxicillin
Gut microbiota
Lead sponsor: Zhongshan Hospital (Xiamen), Fudan University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effects of High-dose Dual therapy combined with probiotics on the gut microbiota for Helicobacter pylori rescue treatment.

Detailed 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 with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this therapy.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years;
* H.pylori infection diagnosed by 13C-urea breath test;
* A period of more than two months since the last eradication therapy for H. pylori;
* Patients who had previously failed 2 or more eradication regimens.

Exclusion Criteria:

* Allergy to any of the medications;
* 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;
* Patients who had used probiotics, vonoprazan, and antibiotics in the past 12 weeks;
* Unwillingness to participate in this study.

Primary outcomes:
measure: Gut Microbiota
timeFrame: day 0, day 44 (or 58), day 104 (or 118)
Secondary outcomes:
measure: Fecal Metabolites
timeFrame: day 0, day 44 (or 58), day 104 (or 118)
measure: Eradication rate
timeFrame: day 44 or day 58
measure: Frequency of the adverse events
timeFrame: day 44 or day 58
measure: Compliance rate of the drugs
timeFrame: day 44 or day 58
measure: Small intestinal bacterial overgrowth
timeFrame: day 0, day 44 (or 58), day 104 (or 118)
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital (Xiamen), Fudan University
state: Fujian
Study officials:
affiliation: Zhongshan Hospital (Xiamen), Fudan University
name: Yucheng Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2;12:881968. doi: 10.3389/fcimb.2022.881968. eCollection 2022.