RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing Esketamine for Irritable Bowel Syndrome

To explore the how well it works of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).

Official registry: https://clinicaltrials.gov/study/NCT06788444 · Beijing Tiantan Hospital · enrollment listed as 552

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are The colonoscopy, or Esketamine. The registry lists allocation as randomized. To explore the how well it works of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).

They plan to enroll about 552 people at Beijing. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: The colonoscopy, Esketamine

Primary outcome (registry wording): The IBS Severity Scoring System (IBS-SSS)

Who it is for (from inclusion criteria)

Ages 18 Years to 60 Years
Age of 18 - 60 years;
American Society of Anesthesiologists (ASA) physical status of I - II;
Body Mass Index (body-mass index (BMI)) of 15 - 30;
Scheduled for colonoscopy;
Positive screening results according to the Rome IV diagnostic criteria for IBS;
Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Anxiety disorder (ANXD) and/or major depressive disorder (major depression)

Who the registry excludes

GastrointestinalTract (GI) bleeding;
Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy；
A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease;
A history of weight loss (at least 10%) within six months;
A history of abdominal surgery (other than hernia repair or appendectomy);
Participate in other clinical trials within 3 months;
Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (recruiting)

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FAQ about this NCT record

Is NCT06788444 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06788444?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06788444?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary