Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity
- Conditions
- Functional Dyspepsia
- Registration Number
- NCT04953975
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
Functional dyspepsia (FD) is a common functional gastrointestinal disease. Several patient-reported outcome questionnaires have been established to evaluate the severity of FD, including Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI). Functional Dyspepsia Symptom Diary (FDSD) is a newly symptom-focused patients-reported outcome measure raised by the Patient-Reported Outcome Consortium's Functional Dyspepsia Working Group. The association of the novel FDSD and other scores-related to FD has not been fully investigated. Furthermore, the severity of FD is varied among different patients. It remains unclear how the moderate and severe FD can be defined by the FDSD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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- 18-70 years old
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- Patients who met the Rome IV diagnostic criteria of FD
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- Normal upper endoscopy and abdominal ultrasonography within one year.
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1, 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 diseases of liver or kidney
- Obvious hematological abnormality, or endocrine and metabolic diseases
- suspected incomplete or complete bowel obstruction
- Known malignancy
- Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
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2, Pregnancy
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3, Inability to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Dyspepsia Symptom Diary 1 day The FDSD consists of 5 cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and 3 supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). Total Symptom Score includes the 5 cardinal items and ranges from 0 to 50.
- Secondary Outcome Measures
Name Time Method Severity of FD judged by patients 1 day Patients were asked to rate the severity of FD as mild, moderate, and severe.
Gastrointestinal Symptom Rating Scale (GSRS) 1 day The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms.
Dyspepsia Symptom Severity Index (DSSI) 1 day The DSSI contains 20 items. All individual items are scored on a 5-point Likert scale (0 = not at all to 4 = extremely) and are subsequently clustered into three domains (Dysmotility-like, Reflux-like, and Ulcer-like); higher scores indicate more severe symptoms.
Short Form of Nepean Dyspepsia Index (SF-NDI) 1 day 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.
Hamilton Anxiety and Depression Scale 1 day Anxiety and depression of patients are assessed by using Hamilton Anxiety and Depression Scale.
Severity of FD judged by physicians 1 day Physicians rated the patients' severity of FD as mild, moderate, and severe.
Trial Locations
- Locations (3)
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shaanxi, China