Effect of MIST on Esophageal Sensitivity in Patients With rGERD

NCT05429034 | Unknown

• 1 other identifier: S65302
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of acute psychosocial stress on esophageal sensitivity in patients with refractory gastro-esophageal reflux disease and healthy volunteers.

Conditions

Stress

Outcome Measures

Primary Outcomes (2)

• Esophageal mechanical sensitivity

  Change in balloon distension

  Assessed during visit 1 at time point 75 minutes

• Esophageal chemical sensitivity

  Change in time for reaching pain threshold

  Assessed during visit 1 at time point 180 minutes

Secondary Outcomes (1)

• Cortisol levels

  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

Study Arms (2)

MIST-paradigm

EXPERIMENTAL

Patients assigned to the MIST paradigm arm are exposed to psychosocial stress.

Behavioral: MIST paradigm

Sham-paradigm

SHAM COMPARATOR

Patients assigned to the sham paradigm are not exposed to psychosocial stress.

Behavioral: Sham paradigm

Interventions

MIST paradigm BEHAVIORAL

Patients are exposed to psychosocial stress = receive mental arithmetic challenges, together with social evaluative threat components from the program and/or the investigator.

MIST-paradigm

Sham paradigm BEHAVIORAL

Patients are not exposed to psychosocial stress = threat components from the program and/or the investigator are absent

Sham-paradigm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

TARGID

Leuven, Vlaams-Brabant, Belgium

RECRUITING

Central Study Contacts

Annelies Geeraerts

CONTACT

+321643385; annelies.geeraerts@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: June 23, 2022
• Study Start: June 1, 2022
• Primary Completion: June 22, 2024
• Study Completion: June 22, 2024
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

BE (1)