Clinical trial NCT04953975: Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity
Official title: Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Dyspepsia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18-70 years old who met the Rome IV diagnostic criteria of FD with normal upper endoscopy and abdominal ultrasonography within one year were eligible for our study. Patients with local or systemic diseases which may cause dyspeptic symptoms were excluded. Patients who were pregnant or unable to give informed consent were also excluded.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional Dyspepsia Symptom Diary
timeFrame: 1 day
Secondary outcomes:
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 1 day
measure: Dyspepsia Symptom Severity Index (DSSI)
timeFrame: 1 day
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 1 day
measure: Hamilton Anxiety and Depression Scale
timeFrame: 1 day
measure: Severity of FD judged by patients
timeFrame: 1 day
measure: Severity of FD judged by physicians
timeFrame: 1 day
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
citation: Shi X, Luo H, Wang X, Ren G, Zhang L, Tao Q, Liang S, Liu N, Huang X, Zhang X, Deng H, Qin W, Kang X, Pan Y, Fan D. Functional dyspepsia symptom diary is correlated with other questionnaires and associated with severity in patients with functional dyspepsia: a multicenter, prospective observational study. J Gastroenterol Hepatol. 2022 Jul;37(7):1298-1306. doi: 10.1111/jgh.15854. Epub 2022 Apr 23.