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New treatment option for Anorexia Nervosa
Official title Gastrointestinal Interoception in Anorexia Nervosa
ClinicalTrials.gov ID: NCT05111977
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- iv. Independently ambulatory v. Possession of a smartphone with data plan vi. English proficiency vii. Willingness and ability to participate in...
- i. Primary clinical diagnosis of anorexia nervosa as defined by Laureate Eating Disorders Program ii. Body mass index ≥ 18.5. iii. Transitioned from...
- 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...
- vii. Independently ambulatory viii. Possession of a smartphone with data plan ix. English proficiency x. Willingness and ability to participate in...
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
What rules you out
- 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...
- 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. people on cardiac doses of aspirin may be...
- 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)...
- 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...
- 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. people on cardiac doses of aspirin may be...
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tulsa, Oklahoma, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tulsa, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.