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Role of oral bacteria in intestinal microbiota affected by proton pump inhibitors: a randomized controlled trial.

Role of oral bacteria in intestinal microbiota affected by proton pump inhibitors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033896
Enrollment
Unknown
Registered
2020-06-15
Start date
2020-06-09
Completion date
Unknown
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Interventions

Group 1:Proton pump inhibitor
Group 2:Proton pump inhibitor +Chloridine mouthwash

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients older than 18 years and younger than or equal to 60 years old; 2. Patients with abdominal pain, reflux and dyspepsia were scored 4 points in GSRS; 3. Patients without major disease (History) in the past; 4. The subjects agreed to sign the informed consent after they were fully informed, and they could understand and comply with the requirements of the trial; 5. Patients who are willing to avoid changes in their main eating habits and avoid strenuous exercise during the intervention.

Exclusion criteria

Exclusion criteria: 1. Patients who have used antibiotics, probiotics, steroids and metformin in the past 3 months; 2. Patients with peptic ulcer and inflammatory bowel disease (ulcerative colitis and Crohn's disease) were definitely diagnosed in the past year; 3. Patients who received oral intervention for periodontal, gingival diseases, caries and / or active oral ulcer in the past month; 4. Previously diagnosed patients with cardiovascular system diseases, metabolic diseases, mental diseases and digestive system tumors, such as hypertension, diabetes, depression, colorectal cancer, etc; 5. Patients with viral / alcoholic / autoimmune / nonalcoholic steatohepatitis and cirrhosis who have been clearly diagnosed before; 6. Patients with family history of digestive system tumor; 7. BMI >= 28kg/m2 8. Patients with bad habits of smoking and drinking; 9. Patients with abnormal defecation frequency (less than 3 times a week or more than 3 times a day); 10. pregnant or lactating women; 11. Patients who participated in other clinical studies in the past month; 12. Patients with previous major gastrointestinal surgery history; 13. The investigator believes that the subjects are unlikely or unable to comply with any conditions or personal conditions of the complete study plan.

Design outcomes

Primary

MeasureTime frame
Gut microbiota16sRNA;Quantifying oral and gut bacteria by PCR;Scale assessment;Tolerance and safety assessment;

Countries

China

Contacts

Public ContactXue Xiao

West China Hospital of Sichuan University

xx_1299@163.com+86 15982175701

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026