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NCT Number: NCT05513040

Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment

Functional dyspepsia (FD) is one of most common chronic gastrointestinal disorders. Several types of drugs were demonstrated to be effective in reduction or remission of symptoms and severity of FD, including proton pump inhibitors (PPI), Tricyclic antidepressant and prokinetics. However, the clinical course of FD after taking medication-based treatment was unknown. Furthermore, 20-50% patients remained persistent or worsening of dyspepsia symptoms after treatment. Previous studies have suggested psychological factors (eg. anxiety, sleep disturbance) were related to less improvement of symptoms in natural clinical course. However, there is limited evidence in terms of clinical and psychological factors for less improvement in patients receiving medication treatment for dyspepsia.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year and older

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

  • age ≥18 years old
  • Patients who met Rome IV criteria
  • Normal upper endoscopy and abdominal ultrasonography within one year

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
  • severe psychiatric illnesses
  • known malignancy
  • pregnancy or lactation
  • unable to provide consent
  • suspected or identified bowel obstruction

Treatment and study plan

Primary outcomes

  1. score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing symptom improvement at 6 months after the initial visit

    Time frame: 6 months

    A 5-point likert scale was used for accessing symptom relief. 1. Worse, 2,slightly worse, 3.same, 4.slightly better, 5.much better. A score of 4 or 5 was classified as relief response.

Secondary outcomes

  1. subtypes of functional dyspepsia

    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.

  2. 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.

  3. Hospital anxiety and depression scale

    Time frame: 1 day

    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.

  4. Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionaire.

    Time frame: 1 day

    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.

  5. the change of Global Overall Symptom score (GOSS)

    Time frame: 1month, 3 months, 6 months,12 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).

  6. Adequate relief rate

    Time frame: 1month, 3 months, 6 months,12 months

    Patients had adequate relief of symptoms in the past 7 days.

  7. the change of Functional dyspepsia symptom diary (FDSD) score

    Time frame: 1month, 3 months, 6 months,12 months

    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).

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2022
Registry last updated
Jun 9, 2026

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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