Clinical trial NCT05760872: Effect of MIST on Esophageal Sensitivity: Pilot Study
Official title: Ffect of Acute Psychosocial Stress on Esophageal Sensitivity in Patients With Refractory Gastro-esophageal Reflux Disease and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cortisol
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers with no or less experience with placing an esophageal probe

Brief summary: Influence of placing the esophageal probe on the cortisol response. Number of cortisol (non)responders and association of heart rate and subjective perception of stress with cortisol levels.

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 (5). 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, 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).

Eligibility criteria: Inclusion Criteria:

Aged between 18 to 65 years. All participants will receive and sign a copy of the informed consent before initiation of the study.

Exclusion Criteria:

* A history of any upper gastrointestinal (GI) symptoms, complaints or diseases;
* Prior history of esophageal or gastric surgery or endoscopic anti-reflux procedure;
* Psychiatric disorders;
* Concomitant use of other medication or treatments except for oral contraceptives;
* Use of medication altering GI motility;
* Pregnant or nursing women;
* History of drugs or alcohol abuse.

Primary outcomes:
measure: cortisol levels
timeFrame: 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, 270
Secondary outcomes:
measure: cortisol responders
timeFrame: up to 4 hours of cortisol measurement
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: TARGID
state: Vlaams-Brabant
Study officials:
References: