RecruitingNot ApplicableNCT05111977

Gastrointestinal Interoception in Anorexia Nervosa

A Neurocomputational Assay of Gastrointestinal Interoception in Anorexia Nervosa

Sponsor

Laureate Institute for Brain Research, Inc.

Enrollment

150 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

Anorexia Nervosa

Summary

Anorexia nervosa (AN) has among the highest mortality rate of any psychiatric illness, yet we have a poor understanding of the biological causes of this disorder. In this study, we use a novel mechanosensory intervention to examine the basic question of whether individuals with AN have abnormal "gut sensations" and whether such indicators are associated with adverse consequences from the disorder.

Eligibility

Sex: FEMALEMin Age: 15 YearsMax Age: 40 Years

Inclusion Criteria5

i. Body mass index ≥ 18.5. ii. Females, ages 15 to 40 years iii. Women of childbearing age: a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study.
iv. Independently ambulatory v. Possession of a smartphone with data plan vi. English proficiency vii. Willingness and ability to participate in study procedures viii. Provision of signed and dated informed consent form
i. Primary clinical diagnosis of anorexia nervosa as defined by Laureate Eating Disorders Program ii. Body mass index ≥ 18.5. iii. Transitioned from acute clinical status rating to residential clinical status or partial/intensive outpatient clinical status rating iv. No new medication prescription in the week prior to study randomization, Must be on a stable dose of medication for at least 1 week.
v. Females, ages 15 to 40 years vi. Women of childbearing age: a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study.
vii. Independently ambulatory viii. Possession of a smartphone with data plan ix. English proficiency x. Willingness and ability to participate in study procedures xi. Provision of signed and dated informed consent form

Exclusion Criteria50

i. Current diagnosis of a psychiatric disorder per the MINI International Diagnostic Interview
ii. Taking any psychotropic medication
iii. Active suicidal ideation with intent or plan
iv. Active cutting or skin lacerating behaviors
v. Active purging behaviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
vi. Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
vii. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
viii. History of complicated/obstructive diverticular disease
ix. Clinical evidence of significant gastroparesis
x. Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
xi. History of intestinal or colonic obstruction, or suspected intestinal obstruction
xii. History of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
xiii. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
xiv. Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
xv. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
xvi. Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
xxv. Orthostatic hypotension (defined as a drop of ≥ 20 mm Hg in systolic BP or a drop of ≥ 10 mm Hg in diastolic BP when measured shortly after transitioning from lying down to standing)
xxvi. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
xxvii. No smartphone/computer or limited access to a smartphone/computer
xxviii. Regular use of any of the following medications or procedures: Medications that may substantially affect intestinal motility, prokinetics at high doses (metoclopramide, erythromycin, senna, prucalopride), anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, enemas
xxix. History of a GI bleed within the last 3 months
xxx. Pelvic floor dysfunction/defecatory disorder, based on subject history
xxxi. Planning to undergo MRI during study time frame
xxxii. Any known allergy to soybean or beeswax or Calcium Carbonate
xxxiii. Bradycardia less than 40 beats per minute
xxxiv. Pain Disorder
i. Active suicidal ideation with intent or plan
ii. Active cutting or skin lacerating behaviors
iii. Active purging behviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
iv. Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
v. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
vi. History of complicated/obstructive diverticular disease
vii. Clinical evidence of significant gastroparesis
viii. Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
ix. History of intestinal or colonic obstruction, or suspected intestinal obstruction
x. History of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
xi. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
xii. Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
xiii. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
xiv. Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
xv. Orthostatic hypotension (defined as a drop of ≥ 20 mm Hg in systolic BP or a drop of ≥ 10 mm Hg in diastolic BP when measured shortly after transitioning from lying down to standing)
xvi. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
xvii. No smartphone/computer or limited access to a smartphone/computer
xviii. Regular use of any of the following medications or procedures: Medications that may substantially affect intestinal motility, prokinetics at high doses (metoclopramide, erythromycin, senna, prucalopride), anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, enemas
xix. History of GI bleed within the last 3 months
xx. Pelvic floor dysfunction/defecatory disorder, based on subject history
xxi. Planning to undergo MRI during study time frame
xxii. Any known allergy to soybean or beeswax, or Calcium Carbonate
xxiii. Bradycardia less than 40 beats per minute
xxiv. Pain Disorder