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Trial Title:
Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology
NCT ID:
NCT05742568
Condition:
Gastritis
Dyspepsia
Helicobacter Pylori Infection
Gastric Cancer
Peptic Ulcer
Conditions: Official terms:
Gastritis
Peptic Ulcer
Dyspepsia
Amoxicillin
Clarithromycin
Esomeprazole
Bismuth
Conditions: Keywords:
Helicobacter pylori
High-dose dual therapy
Bismuth-combining quadruple therapy
Intestinal Microecology
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Esomeprazole
Description:
High-dose dual therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablet TID
plus amoxicillin 500 mg 2 capsules TID
Arm group label:
High-dose dual therapy
Other name:
Nexium
Intervention type:
Drug
Intervention name:
Amoxicillin
Description:
High-dose dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID
plus esomeprazole 20mg 2 tablet TID
Arm group label:
High-dose dual therapy
Other name:
Amoxy
Intervention type:
Drug
Intervention name:
Bismuth
Description:
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2
capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and
clarithromycin 250mg 2 tablets BID
Arm group label:
Bismuth Quadruple Therapy
Intervention type:
Drug
Intervention name:
Esomeprazole
Description:
BBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2
capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and
clarithromycin 250mg 2 tablets BID
Arm group label:
Bismuth Quadruple Therapy
Other name:
Nexium
Intervention type:
Drug
Intervention name:
Amoxicillin
Description:
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2
capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and
clarithromycin 250mg 2 tablets BID
Arm group label:
Bismuth Quadruple Therapy
Intervention type:
Drug
Intervention name:
Clarithromycin
Description:
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2
capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and
clarithromycin 250mg 2 tablets BID
Arm group label:
Bismuth Quadruple Therapy
Summary:
This study was conducted to investigate the effects of high-dose diphtherapy and bismuth
quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the
changes in intestinal microbiota diversity and structure before and after the two
treatment regimens, and to explore the relationship between different treatment regimens
and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of
H. pylori eradication by the two treatment regimens. The expected results are to observe
the changes of intestinal microbiota diversity and structure before and after treatment
with the two treatment regimens.
Detailed description:
The trial can be divided into three phases.
1. Enrollment screening phase: patients who had been clearly diagnosed with Hp
infection and had not received antibiotic therapy and met the inclusion and
exclusion criteria were informed and signed informed consent forms, their basic data
information was collected, medical history and laboratory tests before enrollment
were taken; if they met the requirements of the trial protocol they were included in
the study, and patients' stools were collected for 16S rRNA gene sequencing.
2. Treatment period: Patients were enrolled according to a randomized number table
provided in advance by a third party, and patients were randomized in a 1:1 ratio to
high-dose diphtherapy and bismuth quadruple therapy to receive 2 weeks of Hp
eradication treatment. During the treatment period, patients were provided with
written instructions on how to take the medication, instructed on the correct way to
take the medication, and improved their compliance; patients were asked to record
their symptoms and adverse reactions during the medication period, and were informed
of the visiting telephone number and visiting WeChat, so that they could keep in
touch with the investigator at any time.
3. Follow-up period: At the end of treatment (i.e., day 14 from the start of
treatment), patients were asked to return at that time to have their stools
sequenced for 16S rRNA gene, and 6 weeks after the end of treatment (i.e., day 56
from the start of treatment), patients were asked to return at that time to undergo
rapid urease test (RUT), 13C/14C-urea breath test (13C/14C-UBT), or fecal Hp antigen
test. ) or fecal Hp antigen assay (HpSA), with the results recorded on a CRF form,
and the patient's stool collected for 16S rRNA gene sequencing.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 to 70 years, regardless of gender.
2. Patients with definite Hp infection (positive for either 13C/14C urea breath test,
rapid urease test, and fecal Hp antigen test) and who have not received H. pylori
eradication therapy.
3. Voluntary Hp eradication therapy.
4. Women of childbearing potential are required to use a medically advisable form of
contraception during the trial and for 30 days after the trial ends.
Exclusion Criteria:
1. Patients who have had a definite diagnosis of Hp infection and have been treated
with antibiotic eradication therapy.
2. Patients with contraindications to or allergies to the study drug.
3. Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.),
severe or unstable cardiopulmonary or endocrine disease
4. Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least
2 weeks prior to the screening for Hp infection)
5. Pregnant and lactating women.
6. Having undergone upper gastrointestinal surgery.
7. Have symptoms of dysphagia.
8. Evidence of bleeding or iron deficiency anemia.
9. History of malignancy.
10. History of drug or alcohol abuse within the last 1 year.
11. Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs,
anticoagulants, platelet aggregation inhibitors (except for the use of aspirin ≤100
mg/d)
12. Those with psychiatric disorders.
13. Received other clinical trials within the past 3 months
14. Refusal to sign the informed consent form.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xijing Hosipital of Digestive Disease
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongquan Shi, Ph. D
Phone:
86-29-84771515
Email:
shiyquan@fmmu.edu.cn
Start date:
December 1, 2022
Completion date:
March 10, 2024
Lead sponsor:
Agency:
Xijing Hospital of Digestive Diseases
Agency class:
Other
Source:
Xijing Hospital of Digestive Diseases
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05742568
