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

NCT05749692 | Unknown

• 1 other identifier: KY20221243-F-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia

Keywords

Functional Dyspepsia; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Global Overall Symptom score (GOSS)

  1month, 3 months, 6 months

• subtypes of functional dyspepsia

  6 months

• self-reported severity of symptoms by patients

  1month, 3 months, 6 months

• Other gastrointestinal symptoms

  1month, 3 months, 6 months

• Short Form of Nepean Dyspepsia Index (SF-NDI)

  1month, 3 months, 6 months

Study Arms (1)

The COVID-19 infected group

Functional dyspepsia patients infected with COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study before infection.

You may qualify if:

• aged ≥18 years old
• Patients who met broad criteria of dyspepsia before infection

You may not qualify if:

• organ failure defined by Marshall standard
• severe psychiatric illnesses
• suspected or identified bowel obstruction
• known malignancy
• pregnancy or lactation
• unable to provide consent

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Dyspepsia; COVID-19

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yanglin Pan, MD

CONTACT

13991811225; yanglinpan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 1, 2023
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

CN (1)