NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia

RecruitingNA

Sponsor: Massachusetts General Hospital

Conditions: Functional Dyspepsia, Anorexia Nervosa

Interventions: Functional magnetic resonance imaging (fMRI)

Countries: United States

This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa. The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Participant Inclusion Criteria--

Functional Dyspepsia Group:

* Males and females; ages 18-65 years
* Rome V functional dyspepsia post-prandial distress syndrome subtype
* Negative upper endoscopy or upper GI series to rule out structural/organic cause for FD
* greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
* Fluent in English
* Willing and able to provide informed consent
* Stable dose for 30 days prior to Visit 1 if on a neuropsychiatric medication (e.g., TCA, SNRI, SSRI mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)
* No current plans to initiate a new or change dosing on a neuropsychiatric medication within the study period

Anorexia Nervosa Group:

* Males and females; ages 18-65 years
* DSM-5 anorexia restricting-type by the Eating Disorder Module in the Diagnostic Interview for Mood, Anxiety, and OCD and related Neuropsychiatric Disorders (DIAMOND)
* greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
* Fluent in English
* Willing and able to provide informed consent
* Stable dose for 30 days prior to Visit 1 if on an SSRI
* No current plans to initiate a new neuromodulator
* No current plans to initiate a new SSRI or change dosing on an SSRI

Healthy Controls:

* Males and females; ages 18-65 years
* BMI greater than or equal to 18.5 kg/m2
* Fluent in English
* Willing and able to provide informed consent

Participant Exclusion Criteria--

Functional Dyspepsia Group:

* Presence of other conditions that could explain the patient's symptoms by medical chart:

  * Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT)
  * Active H.pylori (by CLO test or stool antigen test)
  * Active inflammatory bowel disease
  * Eosinophilic gastroenteritis or eosinophilic esophagitis
  * Acute renal failure
  * Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
  * Acute liver failure
  * Any acute gastrointestinal process
  * Any plausible structural or metabolic causes
  * Heartburn as predominant symptom
  * History of peptic ulcer
* Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)
* Endorses any contraindications to MRI
* Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
* Allergy to pineapple (used in the test meal during MRI)
* History of GI tract surgery or any serious medical condition (e.g., cancer)
* Pregnancy/breastfeeding within the last 8 weeks
* Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
* Narcotic analgesics greater than three days per week
* Cannabinoid use greater than three days per week
* Intellectual disability by history
* Illiteracy
* History of weight/shape-based eating disorder including anorexia nervosa by DIAMOND
* Current binge eating by DIAMOND
* Current self-induced vomiting by DIAMOND
* Current laxative or diuretic misuse by DIAMOND
* Current substance/alcohol use disorder within past year by DIAMOND
* Current/history of psychosis by DIAMOND
* Current mania by DIAMOND
* Active suicidal ideation by modified DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
* Inability or unwillingness to consume food by mouth
* Inability to provide informed consent

Anorexia Nervosa Group:

* Diagnosis of chronic gastrointestinal disorder
* Rome V functional dyspepsia
* Endorses any contraindications to MRI
* Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
* Allergy to pineapple (used in the test meal during MRI)
* History of GI tract surgery or any serious medical condition (e.g., cancer)
* Pregnancy/breastfeeding within the last 8 weeks
* Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
* Narcotic analgesics greater than three days per week
* Cannabinoid use greater than three days per week
* Intellectual disability by history
* Illiteracy
* Current binge eating by DIAMOND
* Current self-induced vomiting by DIAMOND
* Current laxative or diuretic misuse by DIAMOND
* Current substance/alcohol use disorder within past year by DIAMOND
* Current/history of psychosis by DIAMOND
* Current mania by DIAMOND
* Active suicidal ideation by DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
* Inability or unwillingness to consume food by mouth
* Inability to provide informed consent
* Current use of neuropsychiatric medication other than an SSRI (e.g., TCA, SNRI, mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)

Healthy Controls:

* Diagnosis of chronic gastrointestinal or pain disorder
* Rome V functional dyspepsia
* greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
* Current use of a medication known to influence gastric sensorimotor functions (including neuromodulators and SSRIs)
* Active psychiatric disorder including a feeding/eating disorder by DIAMOND
* Endorses any contraindications to MRI
* Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
* Allergy to pineapple (used in the test meal during MRI)
* History of GI tract surgery or any serious medical condition (e.g., cancer)
* Pregnancy/breastfeeding within the last 8 weeks
* Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
* Narcotic analgesics greater than three days per week
* Cannabinoid use greater than three days per week
* Intellectual disability by history
* Illiteracy
* Current binge eating by DIAMOND
* Current self-induced vomiting by DIAMOND
* Current laxative or diuretic misuse by DIAMOND
* Current substance/alcohol use disorder within past year by DIAMOND
* Current/history of psychosis by DIAMOND
* Current mania by DIAMOND
* Active suicidal ideation by DIAMOND modified suicide module; passive suicidal ideation is allowed
* Inability or unwillingness to consume food by mouth
* Inability to provide informed consent

Locations (1)

Boston, Massachusetts, United States