RECRUITING

Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions

Conditions

GI Symptoms hypnotherapy disorders of gut-brain interaction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to evaluate if hypnotherapy delivered digitally will help your GI symptoms.

Official Title

The Impact of Gastric Phenotyping in Predicting and Assessing the Clinical Success of Gut-Directed Hypnotherapy for Patients with Gastroduodenal DGBIS.

Quick Facts

Study Start:2025-02-25

Study Completion:2027-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06846359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 untreated 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.	* Patients with known current diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, 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 psychotherapy-based 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. * Patients who are pregnant.

Inclusion Criteria

Exclusion Criteria

* 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 untreated 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.

* Patients with known current diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, 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 psychotherapy-based 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.
* Patients who are pregnant.

Contacts and Locations

Study Contact

Mariah Robran

CONTACT

507-266-3595

Robran.Mariah@mayo.edu

Principal Investigator

Xiao Jing (Iris) Wang, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Xiao Jing (Iris) Wang, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-25

Study Completion Date2027-02-01

Study Record Updates

Study Start Date2025-02-25

Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

hypnotherapy
disorders of gut-brain interaction

Additional Relevant MeSH Terms

GI Symptoms