A Study Of Self-Criticism And Other Negative Views Of Self In Adults With Disorders Of Gut-Brain Interaction

Overview

About this study

The purpose of this study is to assess the perception of self in adults with DGBIs. The purpose is to determine the degree of self-criticism, self-disgust, self-blame, and self-hate in adults with FD and IBS through validated questionnaires. By examining the perception of self in this patient population, it will help provide insight into a psychological component of these GI conditions that has previously been unexplored. The primary endpoint will be determining the mean degree of self-criticism scores in adults with DGBI compared to both healthy controls and patients with other GI conditions (GERD or EoE). Secondary endpoints will be the mean degree of self-disgust, self-blame, and self-hatred compared to both healthy controls and patients with other GI disorders (GERD or EoE). In addition, secondary endpoints also include differences in symptoms of anxiety and depression.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Experimental Group:

Eligible patients for this study will be adult male and female patients greater than the age of 18 with symptoms of functional dyspepsia or IBS meeting Rome IV criteria. In order to be eligible, the patient must already be an established patient in the GI clinic that has had a history, physical, and workup completed to confirm that he or she has FD or IBS based on Rome IV criteria.

Comparison Groups:

Healthy Controls: Adults greater than the age of 18 with no current GI diagnoses and no history of depression or anxiety.
Non-DGBI Comparison Group: Adults greater than the age of 18 with a non-DGBI gastrointestinal disorder, specifically GERD or EoE, and who do not have a medical history of anxiety or depression. Gastroesophageal reflux disease will be defined as the presence of LA Grade B, C, or D erosive esophagitis identified on upper endoscopy or an abnormal pH testing (24-hour pH impedance study or Bravo study). Eosinophilic esophagitis will be defined as the presence of at least 15 eosinophils per high power field identified on biopsies taken from the promixal or middle esophagus and distal esophagus on upper endoscopy.

Exclusion Criteria: None

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/03/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator David Cangemi, M.D.	Contact us for the latest status

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

David Cangemi, M.D.

Contact us for the latest status

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