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

NCT04953975 | Completed DMC

• 1 other identifier: KY20202087-F-2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Gastrointestinal Symptom Rating Scale (GSRS)

  1 day

• Dyspepsia Symptom Severity Index (DSSI)

  1 day

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

  1 day

• Hamilton Anxiety and Depression Scale

  1 day

• Severity of FD judged by patients

  1 day

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

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 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)
• , Pregnancy
• , Inability to give informed consent

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (3)

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710032, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 35434810 DERIVED

Study Design

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

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: November 20, 2020
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-06

Locations

CN (3)