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Effect of MIST on Esophageal Sensitivity in HV (MIST)

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ClinicalTrials.gov Identifier: NCT05427188
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

Brief Summary:
Effect of acute psychosocial stress on esophageal sensitivity in healthy volunteers.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Stress paradigm Behavioral: Sham paradigm Not Applicable

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 (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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: MIST-paradigm
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




Primary Outcome Measures :
  1. Esophageal mechanical sensitivity [ Time Frame: Will be assessed at time point 180 minutes ]
    Change in balloon distention

  2. Esophageal chemical sensitivity [ Time Frame: We be assessed at time point 180 minutes ]
    Change in time for reaching pain threshold


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Annelies Geeraerts +321643385 annelies.geeraerts@kuleuven.be

Locations
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Belgium
TARGID Recruiting
Leuven, Vlaams-Brabant, Belgium
Contact: Annelies Geeraerts    01643385    Annelies.Geeraerts@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Responsible Party: Prof Dr Jan Tack, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT05427188    
Other Study ID Numbers: S65302-HV
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases