The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Functional dyspepsia defined by ROME IV criteria
Study Overview
Brief Summary
Dyspepsia is one of the most common gastrointestinal diseases. This disease was defined as predominant epigastric pain lasting for at least 1 month, which can be accompanied with other symptoms, such as epigastric fullness, and early satiety. Despite dyspepsia symptoms lasting for ≥1 month represented clinical problem, a longer duration of 6 months or more after first-onset symptom was required for the diagnosis of functional dyspepsia based on ROME IV criteria. It was unclear about the natural procession of first-onset dyspepsia to functional dyspepsia assessed by Rome IV or Asia criteria and possible factors associated with this progression.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged ≥ 18 years old who had first-onset dyspepsia with one or more symptoms of epigastric pain, epigastric burning, postprandial fullness, early satiation and that has lasted for more than 1 month to 3 months.
Exclusion Criteria
- •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)
- •organ failure defined by Marshall standard or severe psychiatric illnesses
- •pregnancy or lactation
- •unable to provide consent
Outcomes
Primary Outcomes
Functional dyspepsia defined by ROME IV criteria
Time Frame: 6 months
Met the following criteria: by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
Secondary Outcomes
- Short Form of Nepean Dyspepsia Index (SF-NDI)(1month, 3 months, 6 months)
- Hospital anxiety and depression scale(1month, 3 months, 6 months)
- Self-reported severity of symptoms by patients(1 day)
- Number of participants with other functional gastrointestinal diseases defined by ROME IV criteria(1 day)
- Functional dyspepsia defined by Asia criteria:(3 month)
- Number of participants subclassified into different subtypes of functional dyspepsia defined by ROME IV criteria(6 months)
- Global Overall Symptom score (GOSS)(1month, 3 months, 6 months)
- Quality of Life scores(1month, 3 months, 6 months)
Investigators
Yanglin Pan
professor
Air Force Military Medical University, China