Anorexia NervosaNCT05111977
Gastrointestinal Interoception in Anorexia Nervosa
A study testing Vibrant capsule in people with Anorexia Nervosa, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Vibrant capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HC Inclusion criteria:
- 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.
- 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:
- 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.
- 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.
- 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
Who cannot join
- HC Exclusion criteria:
- Current diagnosis of a psychiatric disorder per the MINI International Diagnostic Interview
- Taking any psychotropic medication
- Active suicidal ideation with intent or plan
- Active cutting or skin lacerating behaviors
- Active purging behaviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
Show all 52Show fewer
- Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
- 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)
- History of complicated/obstructive diverticular disease
- Clinical evidence of significant gastroparesis
- Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
- History of intestinal or colonic obstruction, or suspected intestinal obstruction
- 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
- History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
- Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
- 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
- Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
- 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)
- 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
- History of a GI bleed within the last 3 months
- Pelvic floor dysfunction/defecatory disorder, based on subject history
- 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:
- Active suicidal ideation with intent or plan
- Active cutting or skin lacerating behaviors
- Active purging behviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
- Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
- 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)
- History of complicated/obstructive diverticular disease
- Clinical evidence of significant gastroparesis
- Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
- History of intestinal or colonic obstruction, or suspected intestinal obstruction
- 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
- History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
- Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
- 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
- Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
- 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)
- 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
- 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
- History of GI bleed within the last 3 months
- Pelvic floor dysfunction/defecatory disorder, based on subject history
- Planning to undergo MRI during study time frame
- Any known allergy to soybean or beeswax, or Calcium Carbonate
- xxiii. Bradycardia less than 40 beats per minute
- Pain Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Laureate Institute for Brain Research
Tulsa, Oklahoma, 47136
Colleen McCallum, MBA, cmccallum@laureateinstitute.org
Sahib S Khalsa, MD, PhD
About this study
Official title: A Neurocomputational Assay of Gastrointestinal Interoception in Anorexia Nervosa
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
- Being tested
- Vibrant capsule
- Keywords
- Interoception
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrant capsuleDevice
A capsule delivering mechanical vibrations
| Study group | Role | What they receive |
|---|---|---|
| Capsule stimulation | Experimental | Participants in this arm will receive gastric stimulation via the Vibrant capsule Receives: Device: Vibrant capsule |
| Placebo stimulation | Placebo comparator | Participants in this arm will receive no gastric stimulation via a placebo capsule Receives: Device: Vibrant capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interoceptive precision
Interoceptive sensory precision
Measured: At baseline
Interoceptive prior
Interoceptive prior expectaiton
Measured: At baseline
Learning rate
Interoceptive learning rate
Measured: At baseline
Evoked response potential
Electroencephalogram (EEG) evoked response amplitude within 700 millisecond period following vibration onset
Measured: At baseline
Electrogastrogram
Stomach electrogastrogram (EGG) power in bradygastria, normogastria, tachygastria and total power bands
Measured: At baseline
Secondary outcomes (2)
Normalized A prime
Signal detection accuracy measure
Measured: At baseline
Illness status
Relapse, remission, or recovery status
Measured: At 1 month, 3 month, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Dec 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111977
- Sponsor's protocol ID
- R01MH127225
- Status last verified
- May 2024
- First submitted
- 19 Oct 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will upload the collected data via the NIMH Data Archive (NDA) data repository.
Publications
Verdonk C, Mink K, Choquette E, Moseman SE, Mayeli A, Stewart JL, Paulus MP, Smith R, Khalsa SS. Gastrointestinal Interoception and Relapse in Anorexia Nervosa. JAMA Psychiatry. 2026 Jun 17:e261301. doi: 10.1001/jamapsychiatry.2026.1301. Online ahead of print.
PubMed 42307918
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neurocomputational Assay of Gastrointestinal Interoception in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05111977
- Acronym / sponsor ID
- R01MH127225
- Conditions
- Anorexia Nervosa
- Keywords
- Interoception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule stimulation | Experimental | Device: Vibrant capsuleParticipants in this arm will receive gastric stimulation via the Vibrant capsule |
| Placebo stimulation | Placebo comparator | Device: Vibrant capsuleParticipants in this arm will receive no gastric stimulation via a placebo capsule |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
- 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
- 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.
- 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.
- 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
Key exclusion criteria (52 listed)
- Current diagnosis of a psychiatric disorder per the MINI International Diagnostic Interview
- Taking any psychotropic medication
- Active suicidal ideation with intent or plan
- Active cutting or skin lacerating behaviors
- Active purging behaviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrant capsuleA capsule delivering mechanical vibrations | Device | Capsule stimulation, Placebo stimulation |
Primary outcome
Interoceptive precision
Time frame: At baseline
Interoceptive sensory precision
Interoceptive prior
Time frame: At baseline
Interoceptive prior expectaiton
Learning rate
Time frame: At baseline
Interoceptive learning rate
Evoked response potential
Time frame: At baseline
Electroencephalogram (EEG) evoked response amplitude within 700 millisecond period following vibration onset
Electrogastrogram
Time frame: At baseline
Stomach electrogastrogram (EGG) power in bradygastria, normogastria, tachygastria and total power bands
2 secondary outcomes
Normalized A prime
Time frame: At baseline
Illness status
Time frame: At 1 month, 3 month, and 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 42307918Verdonk C, Mink K, Choquette E, Moseman SE, Mayeli A, Stewart JL, Paulus MP, Smith R, Khalsa SS. Gastrointestinal Interoception and Relapse in Anorexia Nervosa. JAMA Psychiatry. 2026 Jun 17:e261301. doi: 10.1001/jamapsychiatry.2026.1301. Online ahead of print.
- Individual participant dataSharing planned: Yes. We will upload the collected data via the NIMH Data Archive (NDA) data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrant capsule in people with Anorexia Nervosa, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaimee Bruce, BSN (9185025145, JBruce@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interoceptive precision (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.