Clinical trial NCT05823636: The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia
Official title: The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dyspepsia
Keywords: Functional Dyspepsia
uninvestigated dyspepsia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


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:

1. Patients with local or systemic diseases which may cause dyspeptic symptoms:

   Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.
2. Known acute or chronic injury of liver or kidney
3. Obvious hematological abnormality, or endocrine and metabolic diseases
4. Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.
5. Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
6. organ failure defined by Marshall standard or severe psychiatric illnesses
7. pregnancy or lactation
8. unable to provide consent

Primary outcomes:
measure: Functional dyspepsia defined by ROME IV criteria
timeFrame: 6 months
Secondary outcomes:
measure: Functional dyspepsia defined by Asia criteria:
timeFrame: 3 month
measure: Global Overall Symptom score (GOSS)
timeFrame: 1month, 3 months, 6 months
measure: Number of participants subclassified into different subtypes of functional dyspepsia defined by ROME IV criteria
timeFrame: 6 months
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 1month, 3 months, 6 months
measure: Hospital anxiety and depression scale
timeFrame: 1month, 3 months, 6 months
measure: Quality of Life scores
timeFrame: 1month, 3 months, 6 months
measure: Self-reported severity of symptoms by patients
timeFrame: 1 day
measure: Number of participants with other functional gastrointestinal diseases defined by ROME IV criteria
timeFrame: 1 day
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Air Force Military Medical University, China
state: Shaanxi
Study officials:
References: