DyspepsiaNCT05749692
The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia
An observational study of Dyspepsia, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study before infection.
Who may be able to join
- aged ≥18 years old
- Patients who met broad criteria of dyspepsia before infection
Who cannot join
- organ failure defined by Marshall standard
- severe psychiatric illnesses
- suspected or identified bowel obstruction
- known malignancy
- pregnancy or lactation
- unable to provide consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Yanglin Pan, MD, 13991811225, yanglinpan@hotmail.com
About this study
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
- Medical subject headings
- Dyspepsia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The COVID-19 infected group | Functional dyspepsia patients infected with COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1month, 3 months, 6 months
Secondary outcomes (6)
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).
Measured: 1month, 3 months, 6 months
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.
Measured: 6 months
self-reported severity of symptoms by patients
patients rated the severity of FD as mild, moderate, and severe
Measured: 1month, 3 months, 6 months
Other gastrointestinal symptoms
Recurrent lower abdominal pain， dysphoria， altered bowel habit， stool character change， etc.
Measured: 1month, 3 months, 6 months
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.
Measured: 1month, 3 months, 6 months
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.
Measured: 1month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Dec 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749692
- Sponsor's protocol ID
- KY20221243-F-1
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05749692
- Acronym / sponsor ID
- KY20221243-F-1
- Conditions
- Dyspepsia
- Keywords
- Functional Dyspepsia, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The COVID-19 infected group | – | –Functional dyspepsia patients infected with COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study before infection.
Key inclusion criteria (2 listed)
- aged ≥18 years old
- Patients who met broad criteria of dyspepsia before infection
Key exclusion criteria (6 listed)
- organ failure defined by Marshall standard
- severe psychiatric illnesses
- suspected or identified bowel obstruction
- known malignancy
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Global Overall Symptom score (GOSS)
Time frame: 1month, 3 months, 6 months
subtypes of functional dyspepsia
Time frame: 6 months
self-reported severity of symptoms by patients
Time frame: 1month, 3 months, 6 months
Other gastrointestinal symptoms
Time frame: 1month, 3 months, 6 months
Short Form of Nepean Dyspepsia Index (SF-NDI)
Time frame: 1month, 3 months, 6 months
Hospital anxiety and depression scale
Time frame: 1month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspepsia, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan, MD (13991811225, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a score of 1 or 2 (extremely worse) on a 7-Likert scale assessing dyspepsia symptom change (time frame: 1month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.