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New treatment option for GI Symptoms
Official title Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions
ClinicalTrials.gov ID: NCT06846359
What this study is testing
- What it's testing
- The purpose of this research is to evaluate if hypnotherapy delivered digitally will help your GI symptoms.
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients will meet criteria for at least one upper GI DGBI including functional dyspepsia, any nausea/vomiting disorder, or functional abdominal...
- Participants will have had a negative 4-hour solid food gastric emptying test previously or a normal C13 Breath test at screening.
- 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
You likely can't join if
- Patients with known current diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal...
- Patients with current untreated H. pylori infection will be excluded.
- In patients with predominant bloating symptoms and constipation, those with untreated pelvic floor dysfunction will be excluded. If the predominant...
- Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual...
- Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major...
- Patients with substance abuse disorders and drug addiction will be excluded.
See the full eligibility 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...
- Participants will have had a negative 4-hour solid food gastric emptying test previously or a normal C13 Breath test at screening.
- 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)...
- Patients with current untreated H. pylori infection 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.