Effect of MIST on Esophageal Sensitivity in HV

NCT05427188 | Unknown

• 1 other identifier: S65302-HV
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress

Outcome Measures

Primary Outcomes (2)

• Esophageal mechanical sensitivity

  Change in balloon distention

  Will be assessed at time point 180 minutes

• Esophageal chemical sensitivity

  Change in time for reaching pain threshold

  We be assessed 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

HV assigned in the MIST paradigm will receive psychosocial stress

Behavioral: Stress paradigm

Sham-paradigm

SHAM COMPARATOR

HV assigned in the MIST paradigm will receive no psychosocial stress

Behavioral: Sham paradigm

Interventions

Stress paradigm BEHAVIORAL

HV will receive mental arithmetic challenges, together with social evaluative threat components from the program and/or the investigator

MIST-paradigm

Sham paradigm BEHAVIORAL

HV will receive mental arithmetic challenges where threat components from the program and/or the investigator are absent

Sham-paradigm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

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

Record last verified: 2022-06

Locations

BE (1)