StressMISTNCT05429034
Effect of MIST on Esophageal Sensitivity in Patients With rGERD
A study testing MIST paradigm in people with Stress, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Effect of acute psychosocial stress on esophageal sensitivity in patients with refractory gastro-esophageal reflux disease and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress
- What is being tested?
- MIST paradigm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2022to 22 Jun 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 to 65 years;
- Patients need to be classified as having gastroesophageal reflux disease and can be divided in three different groups (based on the Lyon consensus):
- True GERD: Acid exposure time (AET) >6% off PPI or >80 reflux episodes on PPI
- RHS: AET <4% off PPI or <40 reflux episodes on PPI and positive symptom association
- FH: AET <4% off PPI or <40 reflux episodes on PPI and negative symptom association --> Result based on a measurement maximum 1 year ago.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
- Being able to stop PPI intake for 10 - 14 days before the study visit.
Who cannot join
- Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed on PPI treatment;
- Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis);
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed);
- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator;
- Severe anxiety/depressive disorder (assessed with the GAD7, PHQ9 and PHQ15);
- Medication intake that affect sensitivity: anti-depressants (selective serotonin re-uptake inhibitors and tricyclic antidepressants; SSRIs and TCA and daily use of benzodiazepines);
- Pregnancy or breastfeeding;
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
TARGID
Leuven, Vlaams-Brabant
Annelies Geeraerts, 01643385, Annelies.Geeraerts@kuleuven.be
About this study
Official title: Effect of Acute Psychosocial Stress on Esophageal Sensitivity in Patients With Refractory Gastro-esophageal Reflux Disease
Effect of acute psychosocial stress on esophageal sensitivity in patients with refractory gastro-esophageal reflux disease and healthy volunteers.
Read the detailed description
Gastro-esophageal reflux disease (GERD), defined as the presence of symptoms or lesions that can be attributed to the reflux of gastric contents into the esophagus, is an increasingly prevalent condition in Western societies. The most typical symptoms are heartburn and regurgitation, however GERD can also manifest itself through a variety of other esophageal and extra-esophageal symptoms (e.g. chronic cough).
GERD patients can be divided into different categories based on upper endoscopy and pH or impedance-pH (MII-pH) monitoring. In the absence of lesions (esophagitis) during upper endoscopy, a pH or MII-pH monitoring will be performed. A first subcategory are patients with true GERD, characterized by an abnormal acid exposure and a positive or negative symptom association. The second and third category are patients with reflux hypersensitivity (RHS) and functional heartburn (FH)characterized by normal acid exposure on the MII-pH monitoring and a positive and negative symptom reflux association, respectively.
The basis for symptom generation/perception in GERD patients is not yet completely understood, but different mechanisms have been proposed including esophageal hypersensitivity, in which psychosocial stress is considered as a potential factor. This was shown in a study where 64% of the participants with heartburn reported that psychological factors, such as life stress, aggravate their symptoms. Furthermore, Fass et al. observed that auditory stress exacerbated symptom perception during esophageal acid perfusion. Moreover, our group investigated the effect of intravenous corticotrophin releasing hormone (CRH) on esophageal in healthy volunteers and showed that CRH is able to increase esophageal sensitivity to mechanical distention. Nevertheless, these previously performed studies in patients have some limitations: no measurable increase in cortisol (hypothalamo-pituitary-adrenal (HPA)-axis was not affected in these studies) and patients with RHS and FH - in whom the effect of stress is hypothesized to be the most relevant - were not included.
To induce moderate psychologic stress in the current study, the Montreal Imaging Stress Task (MIST) will be used. During this protocol, participants receive mental arithmetic challenges, together with social evaluative threat components from the program and/or the investigator (sham condition: threat components from the program and/or the investigator are absent). This MIST protocol can be used when investigating the effects of perceiving and processing psychosocial stress in the human brain in functional imaging studies.
Therefore, the investigators want to investigate the relation between sensitivity to different stimuli (esophageal sensitivity) and psychosocial stress in healthy volunteers and patients (True GERD, RHS and FH).
- Conditions
- Stress
- Being tested
- MIST paradigm, Sham paradigm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST paradigmBehavioural
Patients are exposed to psychosocial stress = receive mental arithmetic challenges, together with social evaluative threat components from the program and/or the investigator.
Sham paradigmBehavioural
Patients are not exposed to psychosocial stress = threat components from the program and/or the investigator are absent
| Study group | Role | What they receive |
|---|---|---|
| MIST-paradigm | Experimental | Patients assigned to the MIST paradigm arm are exposed to psychosocial stress. Receives: Behavioral: MIST paradigm |
| Sham-paradigm | Sham comparator | Patients assigned to the sham paradigm are not exposed to psychosocial stress. Receives: Behavioral: Sham paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal mechanical sensitivity
Change in balloon distension
Measured: Assessed during visit 1 at time point 75 minutes
Esophageal chemical sensitivity
Change in time for reaching pain threshold
Measured: Assessed during visit 1 at time point 180 minutes
Secondary outcomes (1)
Cortisol levels
change in cortisol levels
Measured: every 15 minutes a saliva sample during 4.5 hours: at time points (in minutes) 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study startJun 2022 (estimated)
- Primary completion22 Jun 2024 (estimated)
- Study completion22 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429034
- Sponsor's protocol ID
- S65302
- Acronym
- MIST
- Status last verified
- Jun 2022
- First submitted
- 20 Oct 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Psychosocial Stress on Esophageal Sensitivity in Patients With Refractory Gastro-esophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05429034
- Acronym / sponsor ID
- MIST / S65302
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- 22 Jun 2024 (estimated)
- Study completion
- 22 Jun 2024 (estimated)
- First posted
- 23 Jun 2022 (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.
Effect of acute psychosocial stress on esophageal sensitivity in patients with refractory gastro-esophageal reflux disease and healthy volunteers.
Detailed description
Gastro-esophageal reflux disease (GERD), defined as the presence of symptoms or lesions that can be attributed to the reflux of gastric contents into the esophagus, is an increasingly prevalent condition in Western societies. The most typical symptoms are heartburn and regurgitation, however GERD can also manifest itself through a variety of other esophageal and extra-esophageal symptoms (e.g. chronic cough).
GERD patients can be divided into different categories based on upper endoscopy and pH or impedance-pH (MII-pH) monitoring. In the absence of lesions (esophagitis) during upper endoscopy, a pH or MII-pH monitoring will be performed. A first subcategory are patients with true GERD, characterized by an abnormal acid exposure and a positive or negative symptom association. The second and third category are patients with reflux hypersensitivity (RHS) and functional heartburn (FH)characterized by normal acid exposure on the MII-pH monitoring and a positive and negative symptom reflux association, respectively.
The basis for symptom generation/perception in GERD patients is not yet completely understood, but different mechanisms have been proposed including esophageal hypersensitivity, in which psychosocial stress is considered as a potential factor. This was shown in a study where 64% of the participants with heartburn reported that psychological factors, such as life stress, aggravate their symptoms. Furthermore, Fass et al. observed that auditory stress exacerbated symptom perception during esophageal acid perfusion. Moreover, our group investigated the effect of intravenous corticotrophin releasing hormone (CRH) on esophageal in healthy volunteers and showed that CRH is able to increase esophageal sensitivity to mechanical distention. Nevertheless, these previously performed studies in patients have some limitations: no measurable increase in cortisol (hypothalamo-pituitary-adrenal (HPA)-axis was not affected in these studies) and patients with RHS and FH - in whom the effect of stress is hypothesized to be the most relevant - were not included.
To induce moderate psychologic stress in the current study, the Montreal Imaging Stress Task (MIST) will be used. During this protocol, participants receive mental arithmetic challenges, together with social evaluative threat components from the program and/or the investigator (sham condition: threat components from the program and/or the investigator are absent). This MIST protocol can be used when investigating the effects of perceiving and processing psychosocial stress in the human brain in functional imaging studies.
Therefore, the investigators want to investigate the relation between sensitivity to different stimuli (esophageal sensitivity) and psychosocial stress in healthy volunteers and patients (True GERD, RHS and FH).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIST-paradigm | Experimental | Behavioral: MIST paradigmPatients assigned to the MIST paradigm arm are exposed to psychosocial stress. |
| Sham-paradigm | Sham comparator | Behavioral: Sham paradigmPatients assigned to the sham paradigm are not exposed to psychosocial stress. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18 to 65 years;
- Patients need to be classified as having gastroesophageal reflux disease and can be divided in three different groups (based on the Lyon consensus):
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
- Being able to stop PPI intake for 10 - 14 days before the study visit.
Key exclusion criteria (8 listed)
- Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed on PPI treatment;
- Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis);
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed);
- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator;
- Severe anxiety/depressive disorder (assessed with the GAD7, PHQ9 and PHQ15);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIST paradigmPatients are exposed to psychosocial stress = receive mental arithmetic challenges, together with social evaluative threat components from the program and/or the investigator. | Behavioural | MIST-paradigm |
| Sham paradigmPatients are not exposed to psychosocial stress = threat components from the program and/or the investigator are absent | Behavioural | Sham-paradigm |
Primary outcome
Esophageal mechanical sensitivity
Time frame: Assessed during visit 1 at time point 75 minutes
Change in balloon distension
Esophageal chemical sensitivity
Time frame: Assessed during visit 1 at time point 180 minutes
Change in time for reaching pain threshold
1 secondary outcome
Cortisol levels
Time frame: every 15 minutes a saliva sample during 4.5 hours: at time points (in minutes) 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 27
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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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?
A study testing MIST paradigm in people with Stress, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 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 23 Jun 2022. 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 Belgium. 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. Some participants in this study may receive a placebo. 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 Annelies Geeraerts (+321643385, annelies.geeraerts@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal mechanical sensitivity (time frame: Assessed during visit 1 at time point 75 minutes). The study lists 2 primary outcomes in all. 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 23 Jun 2022.