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Behavioural Intervention
Vibrant Capsule for Anorexia
N/A
Recruiting
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HC Inclusion criteria: Independently ambulatory
HC Inclusion criteria: Females, ages 15 to 40 years
Must not have
AN Exclusion criteria: History of esophageal disorders
HC Exclusion criteria: Pelvic floor dysfunction/defecatory disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month, 3 month, and 6 month follow-up
Summary
This trial looks at whether people with anorexia have abnormal "gut sensations" and if those indicators are linked to consequences from the disorder.
Who is the study for?
This trial is for females aged 15-40 with anorexia nervosa, a BMI ≥ 18.5, and stable on current medications. Participants must be able to walk, have a smartphone with data, speak English, use birth control if of childbearing age, and provide consent. Exclusions include psychiatric disorders other than AN, certain medication use (affecting gut motility), significant GI disorders or surgeries affecting the gut's structure/function.
What is being tested?
The study tests whether a novel device called the Vibrant capsule can detect abnormal 'gut sensations' in individuals with anorexia nervosa and if these sensations are linked to negative outcomes of the disorder.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort or adverse reactions related to the Vibrant capsule ingestion which is designed to assess gastrointestinal sensation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk on my own without help.
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I am a female aged between 15 and 40.
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I have been diagnosed with anorexia nervosa.
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I am a female aged between 15 and 40.
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I can walk on my own without help.
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I've moved from acute care to a less intensive outpatient or residential care setting.
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I am using reliable birth control methods if I can have children.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had esophageal disorders.
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I do not have pelvic floor dysfunction or defecatory disorders.
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I have never had esophageal disorders.
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I have never had surgery to remove part of my intestines or weight-loss surgery.
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I do not have a condition where my blood pressure drops when I stand up.
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I have never had surgery to remove part of my intestines or weight-loss surgery.
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I do not have a diagnosed pain disorder.
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I have never had a blockage in my intestines or colon.
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I am not taking any psychotropic medications.
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I do not have any specific gastrointestinal conditions.
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I do not have any specific gastrointestinal conditions.
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I do not have a history of serious stomach or intestine problems.
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I do not have a diagnosed pain disorder.
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I do not use NSAIDs regularly.
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I have never had severe diverticular disease.
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I have not had a gastrointestinal bleed in the last 3 months.
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I do not have severe stomach emptying issues.
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I do not have a history of serious stomach or intestine problems.
Select...
I do not have severe stomach emptying issues.
Select...
I do not have pelvic floor dysfunction or defecatory disorder.
Select...
I do not use NSAIDs regularly.
Select...
I have never had a blockage in my intestines or colon.
Select...
I have never had serious issues with diverticular disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month, 3 month, and 6 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month, 3 month, and 6 month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Electrogastrogram
Evoked response potential
Interoceptive precision
+2 moreSecondary study objectives
Illness status
Normalized A prime
Side effects data
From 2019 Phase 4 trial • 59 Patients • NCT044586756%
Other
3%
Diarrhea
3%
Abdominal pain
3%
Headache
3%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Capsule stimulationExperimental Treatment1 Intervention
Participants in this arm will receive gastric stimulation via the Vibrant capsule
Group II: Placebo stimulationPlacebo Group1 Intervention
Participants in this arm will receive no gastric stimulation via a placebo capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibrant capsule
2021
Completed Phase 4
~370
Find a Location
Who is running the clinical trial?
Laureate Institute for Brain Research, Inc.Lead Sponsor
52 Previous Clinical Trials
5,290 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
313 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with anorexia nervosa, but your body mass index is not too low. You have transitioned to a less severe stage of treatment and have not started any new medications in the past week. If you are taking medication, it has been at a stable dose for at least one week.1. You have a healthy weight, with a body mass index (BMI) equal to or greater than 18.5.
2. You are a female between the ages of 15 and 40.
3. If you are of childbearing age, you must use at least two forms of birth control (such as hormonal and barrier methods) during the study.I have never had esophageal disorders.I do not have pelvic floor dysfunction or defecatory disorders.I have never had esophageal disorders.I have never had surgery to remove part of my intestines or weight-loss surgery.I am willing and able to follow the study's procedures.I do not have a condition where my blood pressure drops when I stand up.I have never had surgery to remove part of my intestines or weight-loss surgery.I do not have a diagnosed pain disorder.I have never had a blockage in my intestines or colon.I am willing and able to follow the study's procedures.I am not taking any psychotropic medications.I can walk on my own without help.I am a female aged between 15 and 40.I have been diagnosed with anorexia nervosa.I am a female aged between 15 and 40.I do not have any specific gastrointestinal conditions.I have not had a GI bleed in the last 3 months.I do not have any specific gastrointestinal conditions.I do not have a history of serious stomach or intestine problems.I do not have a diagnosed pain disorder.I can walk on my own without help.I do not have clinical evidence of any listed diseases.I do not use NSAIDs regularly.- You can walk without assistance.
- You have a smartphone with an active data plan.
- You can speak and understand English well.
- You are willing and able to follow the study's procedures.
- You have signed and dated the consent form.You can walk without assistance, have a smartphone with internet access, speak English, and are willing and able to follow the study procedures. You also need to sign a form saying that you understand what the study involves.I do not have clinical evidence of any excluded diseases.I have never had severe diverticular disease.I have not had a gastrointestinal bleed in the last 3 months.I do not have severe stomach emptying issues.I do not have a history of serious stomach or intestine problems.I do not have severe stomach emptying issues.I do not have pelvic floor dysfunction or defecatory disorder.I do not use NSAIDs regularly.I haven't started any new medications in the last week and have been on a stable dose for at least a week.I have never had a blockage in my intestines or colon.I've moved from acute care to a less intensive outpatient or residential care setting.I have never had serious issues with diverticular disease.I am using reliable birth control methods if I can have children.You are a female between 15 to 40 years old and capable of bearing children. If you participate in this study, you must use two forms of birth control, such as a hormonal method and a barrier method, to prevent pregnancy throughout the study.
Research Study Groups:
This trial has the following groups:- Group 1: Capsule stimulation
- Group 2: Placebo stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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