Gastrointestinal Interoception in Anorexia Nervosa

NCT ID: NCT05111977

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Capsule stimulation

Participants in this arm will receive gastric stimulation via the Vibrant capsule

Group Type: EXPERIMENTAL

Vibrant capsule

Intervention Type: DEVICE

A capsule delivering mechanical vibrations

Placebo stimulation

Participants in this arm will receive no gastric stimulation via a placebo capsule

Group Type: PLACEBO_COMPARATOR

Vibrant capsule

Intervention Type: DEVICE

A capsule delivering mechanical vibrations

Interventions

Vibrant capsule

A capsule delivering mechanical vibrations

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Laureate Institute for Brain Research, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jaimee Bruce, BSN

Role: CONTACT

JBruce@laureateinstitute.org

9185025145

Sahib Khalsa, MD

Role: CONTACT

skhalsa@laureateinstitute.org

9185025743

Facility Contacts

Colleen McCallum, MBA

Role: primary

cmccallum@laureateinstitute.org

Other Identifiers

R01MH127225

Identifier Type: NIH

Identifier Source: org_study_id

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