Single low-dose esketamine for irritable bowel syndrome

Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial

This will see if a single low dose of esketamine can quickly reduce IBS symptoms in adults with IBS who also have anxiety or depression and are scheduled for a colonoscopy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 552 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06788444 on ClinicalTrials.gov

What this trial studies

The trial gives a single low dose of esketamine to adults diagnosed with IBS (Rome IV) who also meet DSM-5 criteria for anxiety disorder and/or major depressive disorder and are scheduled for colonoscopy. Eligible participants are 18–60 years old, ASA physical status I–II, and have a BMI of 15–30, while patients with GI bleeding, organic lesions, prior colon cancer, inflammatory bowel disease, celiac disease, recent significant weight loss, or certain abdominal surgeries are excluded. Treatment is administered in conjunction with a scheduled colonoscopy visit and short-term symptom change will be measured to judge rapid efficacy. The protocol also aims to explore connections between psychiatric comorbidity and IBS etiology and treatment response.

Who should consider this trial

Good fit: Adults aged 18–60 with Rome IV–defined IBS who also meet DSM-5 criteria for anxiety disorder and/or major depressive disorder, have ASA I–II status, BMI 15–30, and are scheduled for colonoscopy are ideal candidates.

Not a fit: Patients with organic gastrointestinal disease (such as GI bleeding, colon cancer, inflammatory bowel disease, or celiac disease), recent significant weight loss, certain prior abdominal surgeries, or who do not have coexisting anxiety or depression are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, it could offer a rapid-acting treatment to reduce IBS symptoms, particularly for patients who also have anxiety or depression.

How similar studies have performed: Using esketamine for IBS is largely novel, though ketamine and esketamine have shown rapid effects in depression and have been explored for some pain and visceral hypersensitivity conditions.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Conditions Irritable Bowel Syndrome; Irritable bowel syndrome; esketamine