Eating Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For healthy comparison participants (no eating disorder):

• A body mass index (BMI) of 18.5 or above
• Female, between the ages of 15 and 40
• Women who could become pregnant must use a hormonal method of birth control (such as the pill, implant, or injection) plus a barrier method, or two barrier methods, throughout the study
• Able to walk independently without assistance
• Owner of a smartphone with an active data plan
• Able to read and communicate in English
• Willing and able to take part in all study activities
• Able to provide a signed and dated consent form

For people with anorexia nervosa:

• A primary diagnosis of anorexia nervosa as defined by the Laureate Eating Disorders Program
• A body mass index (BMI) of 18.5 or above
• Has moved from an acute (most intensive) level of care to a residential, partial hospitalisation, or intensive outpatient level of care
• Not having been prescribed any new medications in the week before being enrolled in the study, and on a stable dose of any current medication for at least one week
• Female, between the ages of 15 and 40
• Women who could become pregnant must use a hormonal method of birth control (such as the pill, implant, or injection) plus a barrier method, or two barrier methods, throughout the study
• Able to walk independently without assistance
• Owner of a smartphone with an active data plan
• Able to read and communicate in English
• Willing and able to take part in all study activities
• Able to provide a signed and dated consent form

Who may not be able to join:

For healthy comparison participants:

• People who currently have a diagnosed psychiatric disorder (based on a structured diagnostic interview)
• People currently taking any medication that affects mood, behaviour, or mental health
• People experiencing active thoughts of suicide with a plan or intent to act
• People currently engaging in self-harm through cutting or skin-breaking behaviours
• People currently purging (specifically self-induced vomiting), or with a history of severe self-induced vomiting
• People who are pregnant (confirmed by a urine test) or currently breastfeeding
• People with a significant history of gastrointestinal (digestive system) disorders, such as inflammatory bowel disease or digestive cancers (treated and remitted coeliac disease may be accepted — confirm with trial site)
• People with a history of complicated or obstructive diverticular disease (a bowel condition)
• People with clinical signs of significant gastroparesis (a condition where the stomach empties too slowly)
• People diagnosed with an abnormally large rectum or colon, a birth defect of the rectum or anus, or a significant rectocele or rectal prolapse (confirm with trial site)
• People with a history of intestinal or bowel blockage, or suspected blockage
• People who have had surgery to remove part of the intestine (appendix removal, gallbladder removal, and inguinal hernia repair are exceptions), weight loss surgery, or who have a structural abnormality of the digestive tract that may affect how food moves through the body
• People with a history of certain oesophagus (food pipe) conditions, including Zenker's diverticulum, difficulty swallowing, Barrett's oesophagus, oesophageal narrowing, achalasia, a fistula connecting the oesophagus to the airways, or eosinophilic oesophagitis
• People with clinical evidence of significant lung, heart, kidney, liver, gallbladder, hormonal, or neurological disease (as judged by the investigator)
• People who regularly take full-dose anti-inflammatory pain medications (such as ibuprofen) more than three times a week for at least six months (low-dose aspirin for heart health may be accepted — confirm with trial site)
• People who have a cardiac pacemaker, implantable heart device (defibrillator), implantable drug pump, or a gastric electrical stimulator
• People with orthostatic hypotension, meaning blood pressure drops significantly when standing up from lying down (a drop of 20 mmHg or more in the top number, or 10 mmHg or more in the bottom number)
• People with any other condition that the investigator believes could affect safety or ability to complete the study
• People without access to a smartphone or computer
• People regularly using certain medications or procedures that significantly affect how the bowel moves, including high-dose prokinetics (such as metoclopramide, erythromycin, senna, or prucalopride), anti-Parkinson's medications, opiates or opioids, calcium-channel blockers, or enemas
• People who have had a gastrointestinal (digestive) bleed within the last three months
• People with a history of pelvic floor problems or difficulty with bowel movements
• People planning to have an MRI scan during the study period
• People with a known allergy to soybean, beeswax, or calcium carbonate
• People with a resting heart rate below 40 beats per minute
• People with a diagnosed pain disorder

For people with anorexia nervosa:

• People experiencing active thoughts of suicide with a plan or intent to act
• People currently engaging in self-harm through cutting or skin-breaking behaviours
• People currently purging (specifically self-induced vomiting), or with a history of severe self-induced vomiting
• People who are pregnant (confirmed by a urine test) or currently breastfeeding
• People with a significant history of gastrointestinal (digestive system) disorders, such as inflammatory bowel disease or digestive cancers (treated and remitted coeliac disease may be accepted — confirm with trial site)
• People with a history of complicated or obstructive diverticular disease (a bowel condition)
• People with clinical signs of significant gastroparesis (a condition where the stomach empties too slowly)
• People diagnosed with an abnormally large rectum or colon, a birth defect of the rectum or anus, or a significant rectocele or rectal prolapse (confirm with trial site)
• People with a history of intestinal or bowel blockage, or suspected blockage
• People who have had surgery to remove part of the intestine (appendix removal, gallbladder removal, and inguinal hernia repair are exceptions), weight loss surgery, or who have a structural abnormality of the digestive tract that may affect how food moves through the body
• People with a history of certain oesophagus (food pipe) conditions, including Zenker's diverticulum, difficulty swallowing, Barrett's oesophagus, oesophageal narrowing, achalasia, a fistula connecting the oesophagus to the airways, or eosinophilic oesophagitis
• People with clinical evidence of significant lung, heart, kidney, liver, gallbladder, hormonal, or neurological disease (as judged by the investigator)
• People who regularly take full-dose anti-inflammatory pain medications (such as ibuprofen) more than three times a week for at least six months (low-dose aspirin for heart health may be accepted — confirm with trial site)
• People who have a cardiac pacemaker, implantable heart device (defibrillator), implantable drug pump, or a gastric electrical stimulator
• People with orthostatic hypotension, meaning blood pressure drops significantly when standing up from lying down (a drop of 20 mmHg or more in the top number, or 10 mmHg or more in the bottom number)
• People with any other condition that the investigator believes could affect safety or ability to complete the study
• People without access to a smartphone or computer
• People regularly using certain medications or procedures that significantly affect how the bowel moves, including high-dose prokinetics (such as metoclopramide, erythromycin, senna, or prucalopride), anti-Parkinson's medications, opiates or opioids, calcium-channel blockers, or enemas
• People who have had a gastrointestinal (digestive) bleed within the last three months
• People with a history of pelvic floor problems or difficulty with bowel movements
• People planning to have an MRI scan during the study period
• People with a known allergy to soybean, beeswax, or calcium carbonate
• People with a resting heart rate below 40 beats per minute
• People with a diagnosed pain disorder

Important: Always verify eligibility with the trial site directly before applying.