Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity

Functional Dyspepsia Clinical Trial

Official title:

Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953975
• Other study ID #: KY20202087-F-2
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: June 2021
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 20, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. 18-70 years old
• 2. Patients who met the Rome IV diagnostic criteria of FD
• 3. Normal upper endoscopy and abdominal ultrasonography within one year.

Exclusion Criteria:

• 1, Patients with local or systemic diseases which may cause dyspeptic symptoms:

1. Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.

2. Known acute or chronic diseases of liver or kidney

3. Obvious hematological abnormality, or endocrine and metabolic diseases

4. suspected incomplete or complete bowel obstruction

5. Known malignancy

6. Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)

• 2, Pregnancy
• 3, Inability to give informed consent

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Locations

Country	Name	City	State
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Dyspepsia Symptom Diary	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.	1 day
Secondary	Gastrointestinal Symptom Rating Scale (GSRS)	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.	1 day
Secondary	Dyspepsia Symptom Severity Index (DSSI)	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.	1 day
Secondary	Short Form of Nepean Dyspepsia Index (SF-NDI)	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.	1 day
Secondary	Hamilton Anxiety and Depression Scale	Anxiety and depression of patients are assessed by using Hamilton Anxiety and Depression Scale.	1 day
Secondary	Severity of FD judged by patients	Patients were asked to rate the severity of FD as mild, moderate, and severe.	1 day
Secondary	Severity of FD judged by physicians	Physicians rated the patients' severity of FD as mild, moderate, and severe.	1 day