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

NCT ID: NCT05823636

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Dyspepsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

uninvestigated dyspepsia

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Air Force Military Medical University, China

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanglin Pan, MD

Role: CONTACT

yanglinpan@hotmail.com

13991811225

Facility Contacts

Yanglin Pan, MD

Role: primary

yanglinpan@hotmail.com

13991811225

Other Identifiers

KY20222180-F-5

Identifier Type: -

Identifier Source: org_study_id