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Could a single dose of esketamine ease IBS symptoms?

NCT ID NCT06788444

Symptom relief Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study is testing whether a single low dose of esketamine, given during a colonoscopy, can reduce symptoms of irritable bowel syndrome (IBS) in adults who also have anxiety or depression. The trial plans to enroll 552 participants and will measure symptom severity and quality of life six weeks after the procedure. The goal is to see if this approach provides meaningful relief for people with IBS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
esketamine
What this could lead to
If it works, this could offer a new way to reduce IBS symptoms for people who also have anxiety or depression.
What could go wrong
This is an early-stage trial with no phase, testing only a single dose. The effect may be small or temporary, and esketamine can cause side effects like dizziness or nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 552 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anxiety disorder irritable bowel syndrome major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100050, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.