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The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia

The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05749692
Enrollment
200
Registered
2023-03-01
Start date
2022-12-01
Completion date
2023-08-01
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Keywords

Functional Dyspepsia, COVID-19

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.

Interventions

None listed

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. aged ≥18 years old 2. Patients who met broad criteria of dyspepsia before infection

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

Design outcomes

Primary

MeasureTime frameDescription
a score of 1 or 2 (extremely worse) on a 7-Likert scale assessing dyspepsia symptom change1month, 3 months, 6 monthsThe 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

MeasureTime frameDescription
subtypes of functional dyspepsia6 monthsfunctional 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.
self-reported severity of symptoms by patients1month, 3 months, 6 monthspatients rated the severity of FD as mild, moderate, and severe
Global Overall Symptom score (GOSS)1month, 3 months, 6 monthsThe 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).
Short Form of Nepean Dyspepsia Index (SF-NDI)1month, 3 months, 6 monthsThe 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.
Hospital anxiety and depression scale1month, 3 months, 6 monthsAnxiety 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.
Other gastrointestinal symptoms1month, 3 months, 6 monthsRecurrent lower abdominal pain, dysphoria, altered bowel habit, stool character change, etc.

Countries

China

Contacts

Primary ContactYanglin Pan, MD
yanglinpan@hotmail.com13991811225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026