Overview
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
Inclusion Criteria:
HC Inclusion criteria:
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
AN Inclusion criteria:
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 Criteria:
HC Exclusion criteria:
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
AN Exclusion criteria:
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