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The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia

A

Air Force Military Medical University of People's Liberation Army

Status

Enrolling

Conditions

Dyspepsia

Study type

Observational

Funder types

Other

Identifiers

NCT05823636
KY20222180-F-5

Details and patient eligibility

About

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.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

220 participants in 1 patient group

uninvestigated dyspepsia
Description:
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.

Trial contacts and locations

1

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Central trial contact

Yanglin Pan, MD

Data sourced from clinicaltrials.gov

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