Functional DyspepsiaNCT05513040
Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment
An observational study of Functional Dyspepsia, run by Air Force Military Medical University, China at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 2022to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18 years old who met criteria of functional dyspepsia defined by Rome IV were eligible for our study.
Who may be able to join
- age ≥18 years old
- Patients who met Rome IV criteria
- Normal upper endoscopy and abdominal ultrasonography within one year
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Lanzhou University Second Hospital
Lanzhou, Gansu
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710032
Xijing 986 Hospita
Xi'an, Shaanxi, 710032
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
About this study
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.
- Conditions
- Functional Dyspepsia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 6 months
Secondary outcomes (7)
subtypes of functional dyspepsia
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.
Measured: 6 months
Short Form of Nepean Dyspepsia Index (SF-NDI)
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.
Measured: 1 day
Hospital anxiety and depression scale
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.
Measured: 1 day
Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionaire.
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.
Measured: 1 day
the change of Global Overall Symptom score (GOSS)
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).
Measured: 1month, 3 months, 6 months,12 months
Adequate relief rate
Patients had adequate relief of symptoms in the past 7 days.
Measured: 1month, 3 months, 6 months,12 months
the change of Functional dyspepsia symptom diary (FDSD) score
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).
Measured: 1month, 3 months, 6 months,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513040
- Sponsor's protocol ID
- KY20222180-F-3
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment
- ClinicalTrials.gov ID
- NCT05513040
- Acronym / sponsor ID
- KY20222180-F-3
- Conditions
- Functional Dyspepsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18 years old who met criteria of functional dyspepsia defined by Rome IV were eligible for our study.
Key inclusion criteria (3 listed)
- age ≥18 years old
- Patients who met Rome IV criteria
- Normal upper endoscopy and abdominal ultrasonography within one year
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
subtypes of functional dyspepsia
Time frame: 6 months
Short Form of Nepean Dyspepsia Index (SF-NDI)
Time frame: 1 day
Hospital anxiety and depression scale
Time frame: 1 day
Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionaire.
Time frame: 1 day
the change of Global Overall Symptom score (GOSS)
Time frame: 1month, 3 months, 6 months,12 months
Adequate relief rate
Time frame: 1month, 3 months, 6 months,12 months
the change of Functional dyspepsia symptom diary (FDSD) score
Time frame: 1month, 3 months, 6 months,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia, run by Air Force Military Medical University, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.