The Effect of Multiple Medications on the Incidence of Organic Dyspepsia

Dyspepsia Clinical Trial

Official title:

The Effect of Multiple Medications on the Incidence of Organic Dyspepsia：a Prospective Observational Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524675
• Other study ID #: KY20222180-F-2
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2022
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan
• Phone: 13991811225
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged =18 years old

2. patients who met broad criteria of dyspepsia

3. undergoing upper endoscopy and abdominal ultrasonography within one year.

Exclusion Criteria:

1. organ failure defined by Marshall standard

2. severe psychiatric illnesses

3. suspected or identified bowel obstruction

4. known malignancy

5. pregnancy or lactation

6. unable to provide consent

Related Conditions & MeSH terms

• Dyspepsia

Locations

Country	Name	City	State
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xijing 986 Hospital	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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.	6 months
Secondary	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	6 months
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	Severity of functional dyspepsia judged by patients	Patients rated the severity of functional dyspepsia as mild, moderate, and severe by themselves.	1 day
Secondary	Number of participants with other functional gastrointestinal diseases	Other functional gastrointestinal diseases#such as irritable bowel syndrome(IBS) or functional heartburn#etc.	1 day