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

NCT ID: NCT04953975

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-06-20

Brief Summary

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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

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Conditions

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Functional Dyspepsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35434810 (View on PubMed)

Other Identifiers

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KY20202087-F-2

Identifier Type: -

Identifier Source: org_study_id

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