Gastric Alimetry In Predicting and Assessing of Gut-Directed Hypnotherapy for Patients with Gastroduodenal DGBIS

Overview

About this study

The purpose of this study is to investigate whether a digitally delivered hypnotherapy protocol is efficacious for the treatment of bloating associated with DGBIs, and whether Gastric Alimetry phenotype can predict the clinical success of gut-directed hypnotherapy in patients with gastroduodenal DGBIs.

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:

  • Patients > age 18 years old
  • Patients will meet criteria for at least one upper GI DGBI including functional dyspepsia, any nausea/vomiting disorder, or functional abdominal bloating. Lower GI DGBIs, such as IBS, are allowable if the primary symptom is either an upper GI symptom or bloating/distension.
  • Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method (4h 320kcal egg, 30% fat meal) and will have <25% retained at 4 hours to meet inclusion criteria. Patients with current H. pylori infection will be excluded.
  • Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
  • Patients utilizing cannabinoid based substances may be included if no dose changes are made during the duration of the study
  • Patients will be proficient in English language for comprehension of content
  • Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.

Exclusion Criteria:

  • Patients with known prior diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudoobstruction, advanced connective tissue diseases (e.g. scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
  • In patients with predominant bloating symptoms and constipation, those with untreated pelvic floor dysfunction will be excluded. If the predominant symptoms are nausea/vomiting or dyspepsia, or if constipation is not present, then pelvic floor dysfunction will not be exclusionary.
  • Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded
  • Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded
  • Patients with substance abuse disorders and drug addiction will be excluded.
  • Patients who are unlikely to comply or unlikely to benefit from psychotherapybased interventions may be excluded at the direction of medical screening provider or principal investigator.  
  • Standard inclusion criteria will include: ability to provide informed consent, absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
  • Stable doses medications are permissible but dosing should not be changed during study period.

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

Eligibility last updated 08/23/2024. 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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Xiao Jing Wang, M.D.

Open for enrollment

Contact information:

Xiao Jing Wang M.D.

Wang.Xiao@mayo.edu

More information

Publications

Publications are currently not available