Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT05587127
Eligibility Criteria:
Inclusion Criteria
* Age at least 18 years at screening visit
* Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)
* Negative upper endoscopy or upper radiographic GI series to rule out structural/organic cause for FD
* Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit)
* ≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit)
* Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders)
* No previous history of CBT for functional dyspepsia or ARFID
* Computer/internet webcam access
* Fluency in English
* Stable dose for 30 days if on any medication
Exclusion Criteria
* Inability to provide informed consent
* Presence of other conditions that could explain the patient's symptoms by chart:
Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) Active H.pylori infection (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)
* History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
* History of any serious medical condition (e.g., cancer)
* Use of narcotic analgesics greater than three days per week
* Current pregnancy or breastfeeding within the last 8 weeks
* Uncontrolled diabetes (indicated by HbA1c ≥7%) by chart
* Intellectual disability by history
* Current substance/alcohol use disorder within the past month
* Current/history of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen)
* Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months)
* Active suicidal ideation (by MINI-Screen)
* Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen))
* Current enteral or parenteral feeding
* Plans to initiate another psychotherapy or pregnancy in the concurrent study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05587127
Study Brief:
Protocol Section:
NCT05587127