An observational study in Dyspepsia, sponsored by Air Force Military Medical University, China. Status unknown at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by Air Force Military Medical University, China · Observational
Dyspepsia is a very common gastrointestinal disease, presented as predominant symptom of upper abdominal pain. Underlying causes for dyspepsia can classified as organic or functional dyspepsia. Some medications (eg. non-steroid anti-inflammatory drugs (NSAIDs)) were associated with higher frequent incidences of organic lesions. Multiple medications showed an increased trend with aging of the population and multimorbidity. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which had been reported to lead to higher incidences of some diseases, including fractures, cognitive impairment and malnutrition. However, it was unknown if multiple medications was associated with more incidences of organic dyspepsia.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's planned enrollment of 500 is above the median of 192 across 56 observational studies indexed under Dyspepsia.
Browse Dyspepsia studies →Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.
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Patients aged ≥ 18 years old who met broad criteria of dyspepsia with upper endoscopy and abdominal ultrasonography within one year were eligible for our study.
Exclusion Criteria:
the rate of patients diagnosed with organic upper gastrointestinal (GI) diseases.
All included patients underwent upper GI endoscopy and abdominal ultrasound and H. Pylori test. Barrett's esophagus, esophageal candidiasis, esophageal cancer, gastric ulcer, gastric erosion, gastric cancer, duodenal ulcer, duodenal erosion, cholecystitis, pancreatitis and biliary stones were classified as organic upper GI diseases.
Time frame: 1 day
Functional dyspepsia
Functional dyspepsia was defined by Rome IV criteria, which was based on symptom and duration rather than scores. Patients diagnosed as Rome IV criteria met one or more of following criteria: 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. the above symptoms and durations were included in the questionaire. Physiological parameter was not required for Rome IV criteria.
Time frame: 6 months
Number of participants with different subtypes of functional dyspepsia
Functional dyspepsia was based on Rome IV criteria, which was based on symptom and duration rather than scores. Functional dyspepsia was classified into three subgroups：(1) Postprandial Distress Syndrome, Must include one or both of the following at least 3 days per week: 1. Bothersome postprandial fullness (ie, severe enough to impact on usual activities) 2. Bothersome early satiation (ie, severe enough to prevent finishing a regular-size meal) (2) Bothersome epigastric pain, Must include at least 1 of the following symptoms at least 1 day a week: 1. Bothersome epigastric pain (ie, severe enough to impact on usual activities) AND/OR 2. Bothersome epigastric burning (ie, severe enough to impact on usual activities). (3) mixed syndrome, defined when postprandial distress syndrome and epigastric pain syndrome presented simultaneously
Time frame: 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.
Time frame: 1 day
Hospital anxiety scale
Anxiety of patients are assessed by using Hospital Anxiety Scale.It contains 7 items, which assess symptoms experienced during the past week on a 0-3 scale. A subscore of \> 8 for anxiety would indicate a clinical case.
Time frame: 1 day
Hospital depression scale
Depression of patients are assessed by using Hospital Depression Scale. It contains 7 items, which assess symptoms experienced during the past week on a 0-3 scale. A score of \> 8 for depression would indicate a clinical case.
Time frame: 1 day
Quality of Life scores
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.
Time frame: 1 day
Severity of functional dyspepsia judged by patients
Patients rated the severity of functional dyspepsia as mild, moderate, and severe by themselves.
Time frame: 1 day
Number of participants with other functional gastrointestinal diseases
Other functional gastrointestinal diseases#such as irritable bowel syndrome(IBS) or functional heartburn#etc.
Time frame: 1 day
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China