Gastrointestinal Motility DisorderNCT04988438
Gastrointestinal Motor Disorders (Esophageal and Anorectal) After COVID-19
An observational study of Gastrointestinal Motility Disorder, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal disorder (esophageal and anorectal) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastrointestinal Motility Disorder
- How many people
- 120 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Aug 2021to 31 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients from 20-80 years, men and women.
Who may be able to join
- Patients with esophageal and anorectal symptoms after COVID 19- infection
- Patients with worsening of esophageal and anorectal symptom after COVID 19- infection, but who had previously described esophageal and anorectal symptoms
Who cannot join
- Other gastrointestinal disease that can influence to results
- Gastroesophageal reflux
- H. Pylori infection
- Bacterial, parasitic, viral and fungal gastrointestinal infection or infestation
- Myasthenia
- Scleroderma
- Diabetes mellitus
- Thyroidal hyperfunction
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Prof.dr.sc. Žarko Babić, FEBGH
Zagreb, Select State, 10000
Žarko Babić, prof., +38512903390, zarko.babic@zg.t-com.hr
About this study
Official title: Gastrointestinal Motor Disorders (Esophageal and Anorectal) in Patients After COVID-19 Infection
The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal disorder (esophageal and anorectal) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.
Read the detailed description
The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal (esophageal and anorectal disorder) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.
The patients with dysphagia, chest discomfort during swallowing, or chest pain during swallowing, patients with obstipation, fecal evacuation symptoms, lower stomach discomfort before defecation etc. will be included in the study. In all of them other gastrointestinal diseases will be excluded by standard routine laboratory investigation, ultrasound, routine endoscopy investigation and 24 hours impedance pH-measurement.
After manometric measurement of esophagus and anorectal region to standard protocol by using MMS-HRM 360 monitoring system with 36 canals catheter for esophagus and 24 canals catheter for anorectal monitoring, data will be calculated by using statistics.
- Conditions
- Gastrointestinal Motility Disorder
- Keywords
- After COVID-19, gastrointestinal motility
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 |
|---|---|---|
| esophageal manometry | The patients who has previously mentioned symptoms will underwent to manometry monitoring of esophageal and anorectal disorders. For this investigation we have proven normal and standardized manometric values on previous investigations by other authors, so the control group is not needed. We know the normal manometric values (Chicago 3 score). | |
| anorectal manometry | The patients who has previously mentioned symptoms will underwent to manometry monitoring of esophageal and anorectal disorders. For this investigation we have proven normal and standardized manometric values on previous investigations by other authors, so the control group is not needed. We know the normal manometric values (London protocol). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of esophageal parameters 1 on manometry
In esophagus we will measure Upper and lower esophageal sphincter pressure in mmHg.
Measured: 120 days
Measurement of esophageal parameters 2 on manometry
In esophagus we will measure Integrated relaxation pressure (IRP) in mmHg.
Measured: 120 days
Measurement of esophageal parameters 3 on manometry
In esophagus we will measure Contractile front velocity (CVF) in cm/s.
Measured: 120 days
Measurement of esophageal parameters 4 on manometry
In esophagus we will measure Distal contractile integral (DCI) in mmHg.s.cm.
Measured: 120 days
Measurement of esophageal parameters 5 on manometry
In esophagus we will measure Distal latency (DL) in seconds.
Measured: 120 days
Measurement of esophageal parameters 6 on manometry
In esophagus we will measure Peristaltic brake (BR) in cm.
Measured: 120 days
Measurement of anorectal parameters 1 on manometry
On anorectal manometry we will measure Resting test pressure in mmHg.
Measured: 2 years
Measurement of anorectal parameters 2 on manometry
On anorectal manometry we will measure Squeeze test pressure in mmHg.
Measured: 2 years
Measurement of anorectal parameters 3 on manometry
On anorectal manometry we will measure Endurance squeeze test pressure in mmHg.
Measured: 2 years
Measurement of anorectal parameters 4 on manometry
On anorectal manometry we will measure recto-anal inhibitory reflex test (RAIR)- relaxation in percent.
Measured: 2 years
Measurement of anorectal parameters 5 on manometry
On anorectal manometry we will measure Push test pressure in mmHg.
Measured: 2 years
Measurement of anorectal parameters 6 on manometry
On anorectal manometry we will measure Sensation test with ml in balloon.
Measured: 2 years
Measurement of anorectal parameters 7 on manometry
On anorectal manometry we will measure Balloon expulsion test as positive or negative.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start15 Aug 2021
- Primary completion30 Sep 2021
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Motility DisorderStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Žarko Babić, University Hospital Dubrava
- Investigators
- Žarko B Babić, prof.dr.sc., Principal investigator, Head od Interventional gastroenterology UH Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988438
- Sponsor's protocol ID
- 2021/1407-03UHD
- Status last verified
- Sep 2021
- First submitted
- 27 Jul 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Babic Z, Bezdrov L, Haber VE, Kardum D, Andabak M, Rob Z, Banic M. Esophageal motility disorders after COVID-19 infection. Sci Rep. 2025 Dec 6;16(1):1428. doi: 10.1038/s41598-025-31067-1.
PubMed 41353487
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Motor Disorders (Esophageal and Anorectal) in Patients After COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04988438
- Acronym / sponsor ID
- 2021/1407-03UHD
- Conditions
- Gastrointestinal Motility Disorder
- Keywords
- After COVID-19, gastrointestinal motility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 3 Aug 2021 (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.
The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal disorder (esophageal and anorectal) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.
Detailed description
The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal (esophageal and anorectal disorder) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.
The patients with dysphagia, chest discomfort during swallowing, or chest pain during swallowing, patients with obstipation, fecal evacuation symptoms, lower stomach discomfort before defecation etc. will be included in the study. In all of them other gastrointestinal diseases will be excluded by standard routine laboratory investigation, ultrasound, routine endoscopy investigation and 24 hours impedance pH-measurement.
After manometric measurement of esophagus and anorectal region to standard protocol by using MMS-HRM 360 monitoring system with 36 canals catheter for esophagus and 24 canals catheter for anorectal monitoring, data will be calculated by using statistics.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esophageal manometry | – | –The patients who has previously mentioned symptoms will underwent to manometry monitoring of esophageal and anorectal disorders. For this investigation we have proven normal and standardized manometric values on previous investigations by other authors, so the control group is not needed. We know the normal manometric values (Chicago 3 score). |
| anorectal manometry | – | –The patients who has previously mentioned symptoms will underwent to manometry monitoring of esophageal and anorectal disorders. For this investigation we have proven normal and standardized manometric values on previous investigations by other authors, so the control group is not needed. We know the normal manometric values (London protocol). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients from 20-80 years, men and women.
Key inclusion criteria (2 listed)
- Patients with esophageal and anorectal symptoms after COVID 19- infection
- Patients with worsening of esophageal and anorectal symptom after COVID 19- infection, but who had previously described esophageal and anorectal symptoms
Key exclusion criteria (8 listed)
- Other gastrointestinal disease that can influence to results
- Gastroesophageal reflux
- H. Pylori infection
- Bacterial, parasitic, viral and fungal gastrointestinal infection or infestation
- Myasthenia
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
Measurement of esophageal parameters 1 on manometry
Time frame: 120 days
In esophagus we will measure Upper and lower esophageal sphincter pressure in mmHg.
Measurement of esophageal parameters 2 on manometry
Time frame: 120 days
In esophagus we will measure Integrated relaxation pressure (IRP) in mmHg.
Measurement of esophageal parameters 3 on manometry
Time frame: 120 days
In esophagus we will measure Contractile front velocity (CVF) in cm/s.
Measurement of esophageal parameters 4 on manometry
Time frame: 120 days
In esophagus we will measure Distal contractile integral (DCI) in mmHg.s.cm.
Measurement of esophageal parameters 5 on manometry
Time frame: 120 days
In esophagus we will measure Distal latency (DL) in seconds.
Measurement of esophageal parameters 6 on manometry
Time frame: 120 days
In esophagus we will measure Peristaltic brake (BR) in cm.
Measurement of anorectal parameters 1 on manometry
Time frame: 2 years
On anorectal manometry we will measure Resting test pressure in mmHg.
Measurement of anorectal parameters 2 on manometry
Time frame: 2 years
On anorectal manometry we will measure Squeeze test pressure in mmHg.
Measurement of anorectal parameters 3 on manometry
Time frame: 2 years
On anorectal manometry we will measure Endurance squeeze test pressure in mmHg.
Measurement of anorectal parameters 4 on manometry
Time frame: 2 years
On anorectal manometry we will measure recto-anal inhibitory reflex test (RAIR)- relaxation in percent.
Measurement of anorectal parameters 5 on manometry
Time frame: 2 years
On anorectal manometry we will measure Push test pressure in mmHg.
Measurement of anorectal parameters 6 on manometry
Time frame: 2 years
On anorectal manometry we will measure Sensation test with ml in balloon.
Measurement of anorectal parameters 7 on manometry
Time frame: 2 years
On anorectal manometry we will measure Balloon expulsion test as positive or negative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 41353487Babic Z, Bezdrov L, Haber VE, Kardum D, Andabak M, Rob Z, Banic M. Esophageal motility disorders after COVID-19 infection. Sci Rep. 2025 Dec 6;16(1):1428. doi: 10.1038/s41598-025-31067-1.
- Individual participant dataSharing planned: Undecided
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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.
Žarko B Babić, prof.dr.sc. principal investigator
Head od Interventional gastroenterology UH Dubrava
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 Gastrointestinal Motility Disorder, run by University Hospital Dubrava at 1 site in Croatia.
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 8 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 30 Sep 2021. 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 Croatia. 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 Žarko Babić, prof.dr.sc. (+38512903390, zarko.babic@zg.t-com.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of esophageal parameters 1 on manometry (time frame: 120 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988438, which also lists 1 linked publication.
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 30 Sep 2021.