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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749692
• Other study ID #: KY20221243-F-1
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2023
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan, MD
• Phone: 13991811225
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 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 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

Related Conditions & MeSH terms

• COVID-19
• Dyspepsia

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xian	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	a score of 1 or 2 (extremely worse) on a 7-Likert scale assessing dyspepsia symptom change	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.	1month, 3 months, 6 months
Secondary	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).	1month, 3 months, 6 months
Secondary	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.	6 months
Secondary	self-reported severity of symptoms by patients	patients rated the severity of FD as mild, moderate, and severe	1month, 3 months, 6 months
Secondary	Other gastrointestinal symptoms	Recurrent lower abdominal pain, dysphoria, altered bowel habit, stool character change, etc.	1month, 3 months, 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.	1month, 3 months, 6 months
Secondary	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.	1month, 3 months, 6 months