The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- a score of 1 or 2 (extremely worse) on a 7-Likert scale assessing dyspepsia symptom change
Study Overview
Brief Summary
Although respiratory symptoms were predominant in patients infected with COVID-19, gastrointestinal symptoms were always reported in about 10% patients. Previous studies demonstrated that the SARS-CoV-2 virus still persists in stool samples for a long time after initial infection. Moreover, some patients had a longer duration of COVID-19-related gastrointestinal symptoms, which was defined as "post-acute COVID-19 syndrome".
Previous studies have shown that functional gastrointestinal disorders may occur after acute gastroenteritis. Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. FD was reported to be correlated with multiple pathophysiological mechanisms, including GI bacterial imbalance, disordered gut microbiota, and disturbed barrier and immune function. It is unknown whether COVID-19 infection could exacerbate the symptoms of FD. Therefore, we followed up a group of FD patients before and after COVID-19 and investigate the impact of COVID-19 infection on the symptoms of FD.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged ≥18 years old
- •Patients who met broad criteria of dyspepsia before infection
Exclusion Criteria
- •organ failure defined by Marshall standard
- •severe psychiatric illnesses
- •suspected or identified bowel obstruction
- •known malignancy
- •pregnancy or lactation
- •unable to provide consent
Outcomes
Primary Outcomes
a score of 1 or 2 (extremely worse) on a 7-Likert scale assessing dyspepsia symptom change
Time Frame: 1month, 3 months, 6 months
The patients were interviewed to answer the question "Compared with condition before infection, how about is your gut condition now?" The following questions were chosen: (1) extremely worse, (2) worse, (3) slightly worse, (4) same as before, (5) slightly better, (6) better or (7) much better.
Secondary Outcomes
- Short Form of Nepean Dyspepsia Index (SF-NDI)(1month, 3 months, 6 months)
- self-reported severity of symptoms by patients(1month, 3 months, 6 months)
- Global Overall Symptom score (GOSS)(1month, 3 months, 6 months)
- subtypes of functional dyspepsia(6 months)
- Other gastrointestinal symptoms(1month, 3 months, 6 months)
- Hospital anxiety and depression scale(1month, 3 months, 6 months)
Investigators
Yanglin Pan
professor
Air Force Military Medical University, China