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NCT Number: NCT05823636

The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia

Dyspepsia is one of the most common gastrointestinal diseases. This disease was defined as predominant epigastric pain lasting for at least 1 month, which can be accompanied with other symptoms, such as epigastric fullness, and early satiety. Despite dyspepsia symptoms lasting for ≥1 month represented clinical problem, a longer duration of 6 months or more after first-onset symptom was required for the diagnosis of functional dyspepsia based on ROME IV criteria. It was unclear about the natural procession of first-onset dyspepsia to functional dyspepsia assessed by Rome IV or Asia criteria and possible factors associated with this progression.

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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Air Force Military Medical University, China

Xi'an, Shaanxi, 710032, China

Location status: Recruiting

Location contact

Yanglin Pan, MD

CONTACT

[email protected]

13991811225

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged ≥ 18 years old who had first-onset dyspepsia with one or more symptoms of epigastric pain, epigastric burning, postprandial fullness, early satiation and that has lasted for more than 1 month to 3 months.

Exclusion criteria

  • 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 injury of liver or kidney
  • Obvious hematological abnormality, or endocrine and metabolic diseases
  • Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.
  • Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
  • organ failure defined by Marshall standard or severe psychiatric illnesses
  • pregnancy or lactation
  • unable to provide consent

Treatment and study plan

Primary outcomes

  1. Functional dyspepsia defined by ROME IV criteria

    Time frame: 6 months

    Met the following criteria: by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.

Secondary outcomes

  1. Functional dyspepsia defined by Asia criteria:

    Time frame: 3 month

    Met the following criteria: by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, the symptoms duration≧3 months.

  2. Global Overall Symptom score (GOSS)

    Time frame: 1month, 3 months, 6 months

    The GOSS consists of 10 cardinal items (epigastric pain, epigastric discomfort, Heartburn, acid regurgitation, upper abdominal bloating, belching, nausea, early satiety, postprandial fullness, other epigastric symptoms(eg. epigastric burning). Each item can be scored from 1 (no) to 7 (worst).

  3. Number of participants subclassified into different subtypes of functional dyspepsia defined by ROME IV criteria

    Time frame: 6 months

    Functional dyspepsia was classified into three subgroups：(1) Postprandial Distress Syndrome, defined as Bothersome postprandial fullness or/and Bothersome early satiation. (2) Bothersome epigastric pain AND/OR Bothersome epigastric burning. (3) mixed syndrome, defined when postprandial distress syndrome and epigastric pain syndrome presented simultaneously.

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

    Time frame: 1month, 3 months, 6 months

    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.

  5. Hospital anxiety and depression scale

    Time frame: 1month, 3 months, 6 months

    Anxiety and depression of patients are assessed by using Hospital Anxiety and Depression Scale.It contains 14 items (7 anxiety and 7 depression), which assess symptoms experienced during the past week on a 0-3 scale. A subscore of > 8 for depression or anxiety would indicate a clinical case.

  6. Quality of Life scores

    Time frame: 1month, 3 months, 6 months

    Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionnaire. PROMIS Global-10 is a newly validated 10-question survey used to assess health care-related quality of life measures for the general population.

    It's a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient and a better quality of life.

  7. Self-reported severity of symptoms by patients

    Time frame: 1 day

    Patients rated the severity of dyspepsia as mild, moderate, and severe by themselves

  8. Number of participants with other functional gastrointestinal diseases defined by ROME IV criteria

    Time frame: 1 day

    Recurrent functional dysphagia， reflux hypersensitivity， irritable bowel syndrome， etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanglin Pan, MD

CONTACT

[email protected]

13991811225

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2023
Registry last updated
Sep 26, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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