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

NCT05823636 | Recruiting

• 1 other identifier: KY20222180-F-5
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

Functional Dyspepsia; uninvestigated dyspepsia

Outcome Measures

Primary Outcomes (1)

• Functional dyspepsia defined by ROME IV criteria

  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.

  6 months

Secondary Outcomes (8)

• Functional dyspepsia defined by Asia criteria:

  3 month

• Global Overall Symptom score (GOSS)

  1month, 3 months, 6 months

• Number of participants subclassified into different subtypes of functional dyspepsia defined by ROME IV criteria

  6 months

• Short Form of Nepean Dyspepsia Index (SF-NDI)

  1month, 3 months, 6 months

• Hospital anxiety and depression scale

  1month, 3 months, 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Military Medical University, China

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yanglin Pan, MD

CONTACT

13991811225; yanglinpan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 21, 2023
• Study Start: January 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)