Efficacy of Esketamine for Patients with Irritable Bowel Syndrome

Launched by BEIJING TIANTAN HOSPITAL · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a low dose of esketamine can help patients with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition that can cause symptoms like stomach pain, bloating, and changes in bowel habits. The study aims to find out if esketamine can improve these symptoms for people who are dealing with IBS.

To be eligible to participate, individuals must be between 18 and 60 years old and have a body mass index (BMI) between 15 and 30. They should also be scheduled for a colonoscopy and meet certain diagnostic criteria for IBS, as well as have a diagnosis of anxiety or depression. However, some people may not qualify, including those with a history of serious gastrointestinal issues or mental health conditions that could complicate their participation. Participants can expect to receive a single dose of esketamine and will be monitored for its effects on their IBS symptoms. This study is not yet recruiting volunteers, but it aims to provide valuable information about potential new treatments for IBS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age of 18 - 60 years;
• • 2. American Society of Anesthesiologists (ASA) physical status of I - II;
• • 3. Body Mass Index (BMI) of 15 - 30;
• • 4. Scheduled for colonoscopy;
• • 5. Positive screening results according to the Rome IV diagnostic criteria for IBS;
• • 6. Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Anxiety disorder (ANXD) and/or major depressive disorder (MDD) .
• Exclusion Criteria:
• • 1. GastrointestinalTract (GI) bleeding;
• • 2. Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy；
• • 3. A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease;
• • 4. A history of weight loss (at least 10%) within six months;
• • 5. A history of abdominal surgery (other than hernia repair or appendectomy);
• • 6. Participate in other clinical trials within 3 months;
• • 7. Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；
• • 8. Mental disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year;
• • 9. Allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism;
• • 10. Drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week;
• • 11. Pregnancy or breastfeeding.