The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dyspepsia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Functional dyspepsia defined by ROME IV criteria [Time frame: 6 months]
Secondary outcome measures (8)
- Functional dyspepsia defined by Asia criteria: [Time frame: 3 month]
- Global Overall Symptom score (GOSS) [Time frame: 1month, 3 months, 6 months]
- Number of participants subclassified into different subtypes of functional dyspepsia defined by ROME IV criteria [Time frame: 6 months]
- Short Form of Nepean Dyspepsia Index (SF-NDI) [Time frame: 1month, 3 months, 6 months]
- Hospital anxiety and depression scale [Time frame: 1month, 3 months, 6 months]
- Quality of Life scores [Time frame: 1month, 3 months, 6 months]
- Self-reported severity of symptoms by patients [Time frame: 1 day]
- Number of participants with other functional gastrointestinal diseases defined by ROME IV criteria [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Air Force Military Medical University, China — Xi'an
Identifiers
NCT: NCT05823636 · KY20222180-F-5