Irritable Bowel SyndromeNCT06788444
Efficacy of Esketamine for Patients With Irritable Bowel Syndrome
A study testing The colonoscopy and Esketamine in people with Irritable Bowel Syndrome, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- The colonoscopy and Esketamine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 - 60 years;
- American Society of Anesthesiologists (ASA) physical status of I - II;
- 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 (MDD) .
Who cannot join
- 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;
Show all 11Show fewer
- Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；
- Mental disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year;
- Allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism;
- Drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week;
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Fang Luo, M.D, +86 13611326978, 13611326978@163.com
Zhe Sun, +8615801624623, sunzhe199203@126.com
About this study
Official title: Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial
To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- The colonoscopy, Esketamine
- Keywords
- Irritable bowel syndrome, esketamine
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The colonoscopyProcedure or surgery
Both groups continued to receive the usual standard of gastroenterology care throughout the study period. The patients undergo preoperative preparation according to the requirements of colonoscopy. After entering the endoscopy room, the routine monitoring including electrocardiogram, heart rate, noninvasive blood pressure (BP), respiratory rate, and oxygen saturation (SpO2) are applied for patients. All monitoring data including HR, BP and SpO2 will be recorded at intervals of 3min. Safety assessments will be performed throughout the the research process. As a risk mitigation measure, esketamine should not be administered in patients with systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) >90 mmHg prior to administration.
After the right upper limb venous access is opened, the patients is placed in the left lateral position. The oxygen mask is placed near the patients' nose and oxygen is provided by the mask for 6L/min during the colonoscopy.
EsketamineDrug
The propofol is administered until the patients loss of consciousness (loss of the eyelash refex). The 0.2 mg/kg esketamine is then administered by the anesthesiologist, but should be discontinued if the SBP ≥200 mmHg or the DBP ≥110 mmHg. After the administration of the 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure.
| Study group | Role | What they receive |
|---|---|---|
| The esketamine group | Experimental | The propofol is administered until the patients loss of consciousness. Then 0.2 mg/kg esketamine is then administered by the anesthesiologist. After the administration of 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure. Receives: Procedure: The colonoscopy; Drug: Esketamine |
| The control group | Placebo comparator | The propofol is administered until the patients loss of consciousness. Then normal saline is then administered by the anesthesiologist. After the administration of normal saline is completed, the endoscopist will begin the colonoscopic procedure. Receives: Procedure: The colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The IBS Severity Scoring System (IBS-SSS)
The IBS Severity Scoring System (IBS-SSS) at baseline and at 6 weeks after colonoscopy, which incorporates five typical symptoms of IBS (intensity of abdominal pain, frequency of abdominal pain, intensity of bloating, dissatisfaction with bowel habits, associated interference with daily life) [54-56]. Each symptom score ranges from 0 to 100 and a higher score indicates a more severe symptoms of IBS. The parenteral symptoms incorporates nausea/vomiting, early satiety, heartburn, headache, backache, body aches, thigh pain, lethargy, excess wind, and urinary symptoms. Patients with IBS may be categorized according to IBS-SSS, which are asymptomatic (<75), mild (75-175), moderate (176-300), and severe (>300). A reduction of ≥50 points is considered clinical improvement.
Measured: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
Secondary outcomes (6)
The IBS Quality of Life (IBS-QOL) questionnaire
The IBS Quality of Life (IBS-QOL) questionnaire at baseline and at 6 weeks after colonoscopy, which consists of 8 subscales (dysphoria, activity interference, personal image, health concerns, food avoidance, social reaction, sexuality, social relationship), with a total of 34 questions. Each subscale score ranges from 0 to 100 points. A higher score indicates a better quality of life.
Measured: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The Bristol Stool Form (BSF) scale
The Bristol Stool Form (BSF) scale at baseline and at 6 weeks after colonoscopy, which is used to record the difference in proportions of the patient's daily bowel habits (hard stools, normal stools, and loose stools).
Measured: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) at baseline and at 6 weeks after colonoscopy, which consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.
Measured: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy,
The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score
The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score at baseline and at 6 weeks after colonoscopy, which includes 12 extra-GI symptoms such as back pain, limb pain, and headache. A higher score indicates more severe somatization symptoms.
Measured: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The respiratory and cardiovascular adverse events
The occurrence of the respiratory and cardiovascular adverse events such as tachycardia, elevated BP, hypotension, bradycardia and respiratory depression
Measured: At baseline and at 24 hours after colonoscopy
The other adverse events
The occurrence of the other adverse events such as nausea, vomiting, dizziness, agitation, sedation and hallucinations.
Measured: At baseline and at 24 hours after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start8 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788444
- Sponsor's protocol ID
- KY2024-414-02
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet decided
Publications
Sun Z, Jiang L, Xing Y, Luo F. Efficacy of a single low dose of esketamine for patients with irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2025 Jun 23;15(6):e099793. doi: 10.1136/bmjopen-2025-099793.
PubMed 40550724
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06788444
- Acronym / sponsor ID
- KY2024-414-02
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, esketamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| The esketamine group | Experimental | Procedure: The colonoscopy, Drug: EsketamineThe propofol is administered until the patients loss of consciousness. Then 0.2 mg/kg esketamine is then administered by the anesthesiologist. After the administration of 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure. |
| The control group | Placebo comparator | Procedure: The colonoscopyThe propofol is administered until the patients loss of consciousness. Then normal saline is then administered by the anesthesiologist. After the administration of normal saline is completed, the endoscopist will begin the colonoscopic procedure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age of 18 - 60 years;
- American Society of Anesthesiologists (ASA) physical status of I - II;
- Body Mass Index (BMI) of 15 - 30;
- Scheduled for colonoscopy;
- Positive screening results according to the Rome IV diagnostic criteria for IBS;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The colonoscopyBoth groups continued to receive the usual standard of gastroenterology care throughout the study period. The patients undergo preoperative preparation according to the requirements of colonoscopy. After entering the endoscopy room, the routine monitoring including electrocardiogram, heart rate, noninvasive blood pressure (BP), respiratory rate, and oxygen saturation (SpO2) are applied for patients. All monitoring data including HR, BP and SpO2 will be recorded at intervals of 3min. Safety assessments will be performed throughout the the research process. As a risk mitigation measure, esketamine should not be administered in patients with systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) >90 mmHg prior to administration. After the right upper limb venous access is opened, the patients is placed in the left lateral position. The oxygen mask is placed near the patients' nose and oxygen is provided by the mask for 6L/min during the colonoscopy. | Procedure or surgery | The control group, The esketamine group |
| EsketamineThe propofol is administered until the patients loss of consciousness (loss of the eyelash refex). The 0.2 mg/kg esketamine is then administered by the anesthesiologist, but should be discontinued if the SBP ≥200 mmHg or the DBP ≥110 mmHg. After the administration of the 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure. | Drug | The esketamine group |
Primary outcome
The IBS Severity Scoring System (IBS-SSS)
Time frame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The IBS Severity Scoring System (IBS-SSS) at baseline and at 6 weeks after colonoscopy, which incorporates five typical symptoms of IBS (intensity of abdominal pain, frequency of abdominal pain, intensity of bloating, dissatisfaction with bowel habits, associated interference with daily life) [54-56]. Each symptom score ranges from 0 to 100 and a higher score indicates a more severe symptoms of IBS. The parenteral symptoms incorporates nausea/vomiting, early satiety, heartburn, headache, backache, body aches, thigh pain, lethargy, excess wind, and urinary symptoms. Patients with IBS may be categorized according to IBS-SSS, which are asymptomatic (<75), mild (75-175), moderate (176-300), and severe (>300). A reduction of ≥50 points is considered clinical improvement.
6 secondary outcomes
The IBS Quality of Life (IBS-QOL) questionnaire
Time frame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The Bristol Stool Form (BSF) scale
Time frame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy,
The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score
Time frame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy
The respiratory and cardiovascular adverse events
Time frame: At baseline and at 24 hours after colonoscopy
The other adverse events
Time frame: At baseline and at 24 hours after colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Derived from this study: PubMed 40550724Sun Z, Jiang L, Xing Y, Luo F. Efficacy of a single low dose of esketamine for patients with irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2025 Jun 23;15(6):e099793. doi: 10.1136/bmjopen-2025-099793.
- Individual participant dataSharing planned: No. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The colonoscopy and Esketamine in people with Irritable Bowel Syndrome, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The IBS Severity Scoring System (IBS-SSS) (time frame: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.