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

Recruiting

• Conditions: Dyspepsia

• Registration Number: NCT05823636
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-26
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-10
• Last Update Submitted: 2023-04-10
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional dyspepsia defined by ROME IV criteria	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants subclassified into different subtypes of functional dyspepsia defined by ROME IV criteria	6 months	Functional dyspepsia was classified into three subgroups：(1) Postprandial Distress Syndrome, defined as Bothersome postprandial fullness or/and Bothersome early satiation. (2) Bothersome epigastric pain AND/OR Bothersome epigastric burning. (3) mixed syndrome, defined when postprandial distress syndrome and epigastric pain syndrome presented simultaneously.
Global Overall Symptom score (GOSS)	1month, 3 months, 6 months	The GOSS consists of 10 cardinal items (epigastric pain, epigastric discomfort, Heartburn, acid regurgitation, upper abdominal bloating, belching, nausea, early satiety, postprandial fullness, other epigastric symptoms(eg. epigastric burning). Each item can be scored from 1 (no) to 7 (worst).
Quality of Life scores	1month, 3 months, 6 months	Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionnaire. PROMIS Global-10 is a newly validated 10-question survey used to assess health care-related quality of life measures for the general population.; It's a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient and a better quality of life.
Short Form of Nepean Dyspepsia Index (SF-NDI)	1month, 3 months, 6 months	The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.
Hospital anxiety and depression scale	1month, 3 months, 6 months	Anxiety and depression of patients are assessed by using Hospital Anxiety and Depression Scale.It contains 14 items (7 anxiety and 7 depression), which assess symptoms experienced during the past week on a 0-3 scale. A subscore of \> 8 for depression or anxiety would indicate a clinical case.
Self-reported severity of symptoms by patients	1 day	Patients rated the severity of dyspepsia as mild, moderate, and severe by themselves
Number of participants with other functional gastrointestinal diseases defined by ROME IV criteria	1 day	Recurrent functional dysphagia， reflux hypersensitivity， irritable bowel syndrome， etc.
Functional dyspepsia defined by Asia criteria:	3 month	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, the symptoms duration≧3 months.

Trial Locations

Locations (1)

Air Force Military Medical University, China; 🇨🇳 Xi'an, Shaanxi, China