Actively Recruiting

Phase Not Applicable
Age: 15Years - 40Years
FEMALE
Healthy Volunteers
NCT05111977

Gastrointestinal Interoception in Anorexia Nervosa

Led by Laureate Institute for Brain Research, Inc. · Updated on 2024-05-10

150

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Gastrointestinal Interoception in Anorexia Nervosa

Who Can Participate

Age: 15Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 15 to 40 years
  • Body mass index of 18.5 or higher
  • For women of childbearing age, use of hormonal and barrier birth control methods throughout the study
  • Independently ambulatory
  • Possession of a smartphone with a data plan
  • Proficiency in English
  • Willingness and ability to participate in study procedures
  • Provision of signed and dated informed consent
  • For anorexia nervosa group: primary clinical diagnosis of anorexia nervosa as defined by Laureate Eating Disorders Program
  • For anorexia nervosa group: transitioned from acute clinical status to residential or outpatient status
  • For anorexia nervosa group: stable medication dose for at least 1 week, with no new prescriptions in the week before randomization
Not Eligible

You will not qualify if you...

  • Current diagnosis of psychiatric disorder (for healthy controls)
  • Use of psychotropic medication (for healthy controls)
  • Active suicidal thoughts with intent or plan
  • Active self-harm behaviors such as cutting or skin laceration
  • Active or history of severe self-induced purging behaviors
  • Pregnancy or lactation
  • Significant gastrointestinal disorders including inflammatory bowel disease or malignancy (except treated celiac disease in remission)
  • History of complicated or obstructive diverticular disease
  • Clinical evidence of significant gastroparesis
  • Diagnosed mega-rectum or colon, congenital anorectal malformation, or significant rectocele or rectal prolapse
  • History or suspicion of intestinal or colonic obstruction
  • History of intestinal resection (except appendectomy, cholecystectomy, inguinal hernia repair) or bariatric surgery
  • History of esophageal disorders such as Zenker's diverticulum, Barrett's esophagus, or eosinophilic esophagitis
  • Clinical evidence of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
  • Chronic use of non-steroidal anti-inflammatory drugs more than three times weekly for six months (except cardiac aspirin)
  • Presence of cardiac pacemaker, defibrillator, infusion device, or gastric electrical stimulator
  • Orthostatic hypotension
  • Any condition that may affect safety or ability to complete the study
  • Lack of or limited access to smartphone or computer
  • Regular use of medications affecting intestinal motility or certain other drug classes
  • History of gastrointestinal bleeding within last 3 months
  • History of pelvic floor dysfunction or defecatory disorder
  • Plans to undergo MRI during study period
  • Known allergy to soybean, beeswax, or calcium carbonate
  • Bradycardia with heart rate less than 40 beats per minute
  • Diagnosis of pain disorder

AI-Screening

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Trial Site Locations

Total: 1 location

1

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States, 47136

Actively Recruiting

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Research Team

J

Jaimee Bruce, BSN

CONTACT

S

Sahib Khalsa, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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