Effect of MIST on Esophageal Sensitivity in HV (MIST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05427188|
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : June 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stress||Behavioral: Stress paradigm Behavioral: Sham paradigm||Not Applicable|
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 (6). 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, we 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of Acute Psychosocial Stress on Esophageal Sensitivity in Healthy Volunteers|
|Estimated Study Start Date :||June 2022|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
HV assigned in the MIST paradigm will receive psychosocial stress
Behavioral: Stress paradigm
HV will receive mental arithmetic challenges, together with social evaluative threat components from the program and/or the investigator
Sham Comparator: Sham-paradigm
HV assigned in the MIST paradigm will receive no psychosocial stress
Behavioral: Sham paradigm
HV will receive mental arithmetic challenges where threat components from the program and/or the investigator are absent
- Esophageal mechanical sensitivity [ Time Frame: Will be assessed at time point 180 minutes ]Change in balloon distention
- Esophageal chemical sensitivity [ Time Frame: We be assessed at time point 180 minutes ]Change in time for reaching pain threshold
- 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 ]Change in cortisol levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427188
|Contact: Annelies Geeraertsemail@example.com|
|Leuven, Vlaams-Brabant, Belgium|
|Contact: Annelies Geeraerts 01643385 Annelies.Geeraerts@kuleuven.be|