Investigating the effects of treating Helicobacter Pylori on dyspepsia symptoms
Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
This study is testing if treating Helicobacter pylori can help people with upset stomach symptoms feel better over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2242 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 26 sites (Chongqing, Chongqing Municipality and 25 other locations) |
| Trial ID | NCT06422052 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, observational study aims to assess the incidence of dyspeptic symptoms in patients infected with Helicobacter pylori. It will follow patients over time to evaluate the remission of these symptoms after receiving eradication treatment for the infection. The study utilizes an epidemiological questionnaire and a Functional Dyspepsia Symptom Diary to gather data on patient experiences and outcomes. The findings are intended to inform clinical diagnosis and treatment strategies for those affected by H. pylori and dyspepsia.
Who should consider this trial
Good fit: Ideal candidates include treatment-naive adults aged 18-80 diagnosed with H. pylori infection.
Not a fit: Patients with severe organic digestive diseases or alarm symptoms, as well as those with a history of cancer or significant organ dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients suffering from dyspepsia related to H. pylori infection.
How similar studies have performed: Other studies have shown success in similar approaches, indicating the potential for effective treatment strategies for H. pylori-related dyspepsia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients aged 18-80 years * H. pylori infection diagnosed by 13C/ 14C-UBT (\> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive) * Treatment-naive patients with Helicobacter pylori * Ability and willingness to participate in the study and to sign and give informed consent Exclusion Criteria: * Under 18 or over 80 years old * Organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc. * Combined with melena, hematemesis, anemia, emaciation and other alarm symptoms * Pregnant and lactating women * History of cancer * History of subtotal gastrectomy * Severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade IV heart failure, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.
Where this trial is running
Chongqing, Chongqing Municipality and 25 other locations
- Chongqing Daping Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
- The Ninth People's Hospital of Chongqing — Chongqing, Chongqing Municipality, China (Recruiting)
- The People's Hospital of Kaizhou District, CQ — Chongqing, Chongqing Municipality, China (Recruiting)
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
- The People's Hospital of Wuwei — Wuwei, Gansu, China (Recruiting)
- The First People's Hospital of Qinzhou — Qinzhou, Guangxi, China (Recruiting)
- The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
- Yongcheng People's Hospital of Henan Province — Shangqiu, Henan, China (Recruiting)
- Xuchang Central Hospital — Xuchang, Henan, China (Recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- Baotou Central Hospital — Baotou, Inner Mongolia, China (Recruiting)
- Dalian Friendship Hospital — Dalian, Liaoning, China (Recruiting)
- The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
- Ruijin Hospital Luwan Branch — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Construction Group Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Putuo Liqun Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Songjiang Central Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- West China Fourth Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Tianjing, Tianjing, China (Recruiting)
- The Second People's Hospital of Kashgar, Xinjiang — Kashgar, Xinjiang, China (Recruiting)
- Second People's Hospital of Jinning District, Kunming City — Kunming, Yunnan, China (Recruiting)
- Ningbo Hangzhou Bay Hospital — Ningbo, Zhejiang, China (Recruiting)
- The People's Hospital of Shengzhou — Ningbo, Zhejiang, China (Recruiting)
- Shengzhou People's Hospital — Shaoxing, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Hong Lu, MD
- Email: hlu@sjtu.edu.cn
- Phone: +8613611958022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.