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NCT Number: NCT04953975

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

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.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lanzhou University Second Hospital, Lanzhou, Gansu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional Dyspepsia Symptom Diary

    Time frame: 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 outcomes

  1. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 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.

  2. Dyspepsia Symptom Severity Index (DSSI)

    Time frame: 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.

  3. Short Form of Nepean Dyspepsia Index (SF-NDI)

    Time frame: 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.

  4. Hamilton Anxiety and Depression Scale

    Time frame: 1 day

    Anxiety and depression of patients are assessed by using Hamilton Anxiety and Depression Scale.

  5. Severity of FD judged by patients

    Time frame: 1 day

    Patients were asked to rate the severity of FD as mild, moderate, and severe.

  6. Severity of FD judged by physicians

    Time frame: 1 day

    Physicians rated the patients' severity of FD as mild, moderate, and severe.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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