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Vibrant Capsule for Anorexia
Study Summary
This trial looks at whether people with anorexia have abnormal "gut sensations" and if those indicators are linked to consequences from the disorder.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Capsule stimulation
- Group 2: Placebo stimulation
- 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.
Frequently Asked Questions
Does the age restriction for this trial preclude those over 30 years of age?
"As stipulated in the trial's enrollment criteria, only individuals aged between 15 and 40 can participate."
How many participants are being recruited for this research trial?
"Affirmative. Per the information found on clinicaltrials.gov, this trial is still actively searching for participants and was initially published on December 1st 2021; it has since been updated as recent as April 4th 2022. 150 individuals must be recruited from a single site in order to fulfil the requirements of this experiment."
Are there specific criteria for potential participants in this medical experiment?
"A total of 150 anorexic individuals aged between 15 and 40 are being admitted into the trial. To be considered for participation, potential participants must possess a body mass index of at least 18.5, be female within this age bracket, independently ambulatory with a smartphone data plan and English proficiency, as well as demonstrate commitment to partake in study procedures by providing signed consent forms. Additionally, those who have recently been prescribed medication or fall under women-of-childbearing age require extra precautions such as hormonal birth control throughout the trajectory of the clinical trial."
Are participants being enrolled at this point in time?
"The medical trial's information on clinicaltrials.gov confirms that it is presently looking for volunteers, having first been posted on December 1st 2021 and last modified on April 4th 2022."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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