Understanding the course of functional dyspepsia and treatment outcomes
Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment
This study looks at how well different medications help people with functional dyspepsia feel better and whether psychological factors play a role in their treatment success.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Locations | 4 sites (Lanzhou, Gansu and 3 other locations) |
| Trial ID | NCT05513040 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the clinical course of functional dyspepsia (FD) in patients receiving medication-based treatment. It will assess the effectiveness of various drugs, including proton pump inhibitors and tricyclic antidepressants, in alleviating symptoms and identify psychological factors that may influence treatment outcomes. The study will include patients who meet specific criteria, such as age and prior medical evaluations, to ensure a focused analysis of treatment efficacy. By examining both clinical and psychological factors, the study seeks to provide insights into why some patients experience persistent symptoms despite treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the Rome IV criteria for functional dyspepsia and have normal upper endoscopy and abdominal ultrasonography results.
Not a fit: Patients with severe psychiatric illnesses, known malignancies, or other significant health conditions causing dyspeptic symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with functional dyspepsia, enhancing their quality of life.
How similar studies have performed: Previous studies have indicated that psychological factors can affect treatment outcomes in functional dyspepsia, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age ≥18 years old 2. Patients who met Rome IV criteria 3. Normal upper endoscopy and abdominal ultrasonography within one year Exclusion Criteria: 1. Patients with local or systemic diseases which may cause dyspeptic symptoms: Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia) 2. organ failure defined by Marshall standard 3. severe psychiatric illnesses 4. known malignancy 5. pregnancy or lactation 6. unable to provide consent 7. suspected or identified bowel obstruction
Where this trial is running
Lanzhou, Gansu and 3 other locations
- Lanzhou University Second Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
- Xijing 986 Hospita — Xi'an, Shaanxi, China (Not_yet_recruiting)
- Xijing Hospital of Digestive Diseases — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yanglin Pan
- Email: yanglinpan@hotmail.com
- Phone: 13991811225
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.