Clinical trial NCT06788444: Efficacy of Esketamine for Patients with Irritable Bowel Syndrome
Official title: Efficacy of a Single Low Dose of Esketamine for Patients with Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
esketamine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Hengshui People's Hospital
First posted: 2025-01-23
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).

Detailed description: The investigators aim to investigate the efficacy of a single low dose of esketamine in patients with irritable bowel syndrome (IBS), and to explore the etiology of IBS and the effective and rapid treatment for this etiology.

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.

Primary outcomes:
measure: The IBS Severity Scoring System (IBS-SSS)
timeFrame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
Secondary outcomes:
measure: The IBS Quality of Life (IBS-QOL) questionnaire
timeFrame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
measure: The Bristol Stool Form (BSF) scale
timeFrame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy,
measure: The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score
timeFrame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
measure: The respiratory and cardiovascular adverse events
timeFrame: At baseline and at 24 hours after colonoscopy
measure: The other adverse events
timeFrame: At baseline and at 24 hours after colonoscopy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: