Ensayos clínicos

Inclusion Criteria:

• Be able to provide informed consent and be willing to sign an Informed Consent Form (ICF).
• Adults who are of the age of majority to 80 years at the time of signing the ICF (minimum representation target of at least 30% per gender).
• History of primary, idiopathic, or secondary CIPO as confirmed by a physician.
• Capable of oral nutrition (including partial oral nutrition).
• Currently resides in US.
• Ability to read, speak and understand English (US English) fluently.
• Be willing and able to participate in up to two interviews lasting approximately 90 minutes in total via a videoconference platform (e.g., MS Teams).
  • Participants may be asked to participate in an additional interview lasting approximately 30 minutes.
• Willing to have the interview audio recorded
  • Note: no video-recording will be made.
• Have reliable access to high-speed internet.

Exclusion Criteria:

• History of any serious psychiatric disorder or other condition (e.g., Alzheimer’s disease, dementia, schizophrenia, or other disorders that impair memory or cognitive function) that could interfere with participant providing informed consent or participating in an interview to discuss about their health with particular reference to their health-related quality of life (HRQoL) and CIPO-related symptoms.
• Active malignancy [a malignant cancer (with the exception of treated intraepithelial neoplasia, basal cell or squamous cell carcinoma of the skin) diagnosed within the previous six months, recurrent, invasive/regionally advanced or metastatic cancer for which treatment had been administered within six months and any form of malignant cancer that is not in complete remission and/or that requires active treatment (including surgery or palliation)].
• Recent abdominal or pelvic surgery (i.e., surgery, including laparoscopic surgery, performed within 6 months prior to screening).
• Any type of late-stage disease treated with palliative care (i.e., end-of-life care) that would prevent completion of the study or interfere with analysis of study results, at the discretion of the investigator.
• Physician-confirmed acute infection (i.e., current use of antibiotic therapy at the time of signing the ICF) involving the GI tract (e.g., viral or bacterial gastroenteritis, acute viral hepatitis) or the abdominal cavity (e.g., cystitis, fungal peritonitis).
• Subjects with conditions characterized by actual (unresolved) mechanical intestinal obstruction (e.g., volvulus, adhesions, hernias, Crohn’s disease, diverticulitis, actual presence of fecalith, or fecal impaction).
• Patients who are on Total Parenteral Nutrition (TPN) (100% reliant on parenteral nutrition) at screening.
• Use of opioids [such as narcotics (including, but not limited to, heroin, morphine and analogue molecules/derivates, oxycodone, hydrocodone, hydromorphone, buprenorphine, fentanyl, codeine), μ agonist, δ-opioid receptor antagonist (e.g., eluxadoline), loperamide] within 2 weeks prior to screening and during study participation.
• Pregnant women.
• Failure to be eligible to participate in the study for any reason or circumstance that, according to the Investigator's judgment, would prevent completion of the study or interfere with analysis of study results (e.g., recent history of alcohol abuse).
• Unwilling or unable to comply with the study procedures.
• Presence of other clinically significant disease that in the Investigator’s opinion could adversely affect the quality of life of the patient or could impair the assessment of study results.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/1/22. Questions regarding updates should be directed to the study team contact.