Irritable Bowel SyndromerTMSNCT07581756
Repeated Transcranial Magnetic Stimulation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial
A study testing rTMS group in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea (IBS-D), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Objectives: This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), and to explore the potential underlying mechanisms by which rTMS alleviates clinical symptoms in IBS-D patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS)
- What is being tested?
- rTMS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Jul 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants had to be between 18- 60 years of age and fulfill the Rome IV criteria for IBS-D. Specifically, patients must have experienced recurrent abdominal pain at least one day per week in the last three months, with symptom onset at least six months prior to diagnosis, associated with defecation or a change in the frequency or form (appearance) of stool. More than 25% of stool episodes be classified as Bristol Stool Form Scale (BSFS) type 6 or 7, and fewer than 25% as type 1 or 2. In addition, patients were required to exhibit moderate to severe symptoms, defined as an Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score greater than 175 (on a 500-point scale). Dietary preferences of all participants included non vegetarian options and participants maintain stable dietary habits for at least one month prior to randomization. Moreover, patients aged over 50 were required to provide documentation of a normal colonoscopy performed within the preceding three years.
Who cannot join
- The exclusion criteria included a completion rate of daily diaries of less than 50% during the screening period, a history of organic gastrointestinal disease, such as inflammatory bowel disease, a history of surgical resection of the GI tract or cholecystectomy, a recent diagnosis of Helicobacter pylori infection within the past 2 years, a history of gluten or lactose intolerance, a history of malignancy, or a history of neurological or psychiatric conditions. Additionally, individuals with severe systemic diseases, including uncontrolled diabetes mellitus, hyperthyroidism, or severe hepatic, renal, or cardiac insufficiency, were excluded. The use of probiotic or prebiotic supplements, antibiotics (including rifaximin), prokinetic or antidiarrheal agents, tricyclic antidepressants, or immunosuppressive therapies was not permitted within 4 wk prior to screening. Prohibited conditions during the study period included pregnancy, lactation, or being within 12 months postpartum. Lastly, participants with severe needle phobia, metal allergies, implanted cardiac pacemakers, or a known allergic diathesis were excluded. All participants provided their voluntary, written, informed consent prior to their inclusion.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Wu Shuangjie, +8651267972743, sdfyec@163.com
Xiuji Kan
About this study
Official title: Repeated Transcranial Magnetic Stimulation (rTMS) for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial
Objectives: This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), and to explore the potential underlying mechanisms by which rTMS alleviates clinical symptoms in IBS-D patients.
Design: This is a clinical trial that uses clinical symptom scales to assess the therapeutic effect of rTMS on IBS-D patients. Meanwhile, gut microbiota and metabolite profiling, as well as the methane-hydrogen breath test, will be applied to investigate the mechanism of action from the perspectives of gut microecology, intestinal motility, and metabolism, so as to provide scientific evidence for the clinical application of rTMS in the treatment of IBS-D.
Read the detailed description
Background: A large number of studies have demonstrated that repetitive transcranial magnetic stimulation (rTMS) can alleviate chronic pain. Its potential mechanisms include modulating cortical excitability, improving cerebral blood flow and metabolism, regulating neurotransmitters and gene expression, and inducing neuroplasticity. Previous findings indicate that the gut-brain neural circuit involving the insular cortex and anterior cingulate cortex serves as a key pathway regulating chronic visceral pain in irritable bowel syndrome (IBS). Studies have also shown that transcranial magnetic stimulation (TMS) can reduce visceral hypersensitivity in patients with IBS. On this basis, the present study further investigates whether rTMS can improve diarrheal symptoms in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), in order to provide a more reliable and effective therapeutic strategy for clinical practice.
Objectives:
This study aims to evaluate the overall clinical efficacy of rTMS in the treatment of IBS-D, including diarrhea, abdominal pain, quality of life, psychiatric symptoms (anxiety and depression), and sleep disturbance. Meanwhile, the underlying mechanisms of rTMS will be explored using gut microbiota and metabolomic profiling, as well as the methane-hydrogen breath test.
Methods:
This is a clinical trial designed to evaluate the efficacy of rTMS in treating chronic diarrhea in IBS-D patients. A total of 46 IBS-D patients meeting eligibility criteria will be randomly assigned to receive either real rTMS (n=23) or sham rTMS (n=23).
The treatment will last for 3 weeks. The real rTMS group will receive 1 Hz stimulation, 20 minutes per session. The sham rTMS group will receive 0 Hz stimulation (sham condition), 20 minutes per session.
Low-frequency rTMS (1 Hz) will be applied over the medial prefrontal cortex (mPFC) using a magnetic stimulator manufactured by Wuhan IRide Company. Stimulation intensity will be set at 80% of the resting motor threshold (RMT). RMT is defined as the minimal stimulus intensity required to evoke a motor evoked potential (MEP) amplitude of ≥50 μV in at least 5 out of 10 consecutive trials.
The coil will be placed tangentially over the mPFC. Patients will remain seated quietly with minimal head movement during the entire session.For the real rTMS group: 1 Hz frequency, 80% RMT intensity, 1100 pulses per session, with each pulse train lasting 2 seconds, and a total session duration of 20 minutes.For the sham rTMS group: the coil is positioned identically but without effective magnetic stimulation, while pre-recorded sound is played to mimic the acoustic feedback of real rTMS.
Outcome Assessments:
Clinical assessments will include diarrhea, abdominal pain, quality of life, intestinal sensitivity, mood status, and sleep.
Mechanistic evaluations will be performed using gut microbiota and metabolite analysis, combined with methane-hydrogen breath test, to explore the mechanisms underlying rTMS effects on chronic diarrhea in IBS-D patients.
Gut microbiota data will be analyzed to compare differences between the treatment and control groups before and after intervention. Correlation analyses will be conducted between clinical improvement and changes in microbial and metabolic profiles.
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS), Chronic Diarrhea, Intestinal Flora
- Being tested
- rTMS group, sham device
- Keywords
- Irritable Bowel Syndrome with diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS)
- 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.
rTMS groupDevice
Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 3 weeks.
sham deviceDevice
Also called sham transcranial magnetic stimulation
For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.
| Study group | Role | What they receive |
|---|---|---|
| repeated transcranial magnetic stimulation group | Active comparator | The rTMS group was given 1 Hz/s for 20 minutes for 3 weeks. Receives: Device: rTMS group |
| sham repetitive transcranial magnetic stimulation group | Sham comparator | For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. Receives: Device: sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite response rate
The primary outcome measure of this study is the composite response rate on Day 14 of treatment; a composite responder is defined as having both a ≥30% reduction in the weekly average of the worst abdominal pain intensity in the past 24 hours compared with baseline and a ≥50% reduction in the weekly number of days with Bristol Stool Form Scale (BSFS) Type 6 or 7 (diarrheal stools) compared with baseline.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
Secondary outcomes (10)
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Changes in the total score of the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) from baseline to Day 21. The IBS-SSS ranges from 0 to 500 points and covers five domains: severity and frequency of abdominal pain, bloating, satisfaction with bowel habits, and impact on quality of life. A reduction of ≥95 points is considered a clinically meaningful improvement.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
Irritable Bowel Syndrome Quality of Life (IBS-QOL)
IBS-QOL is a validated questionnaire assessing quality of life in IBS patients. Scores range 0-100; higher scores reflect better quality of life. A ≥14-point increase indicates clinically significant improvement.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
The Bristol Stool Form Scale (BSFS) and Frequency of defecation
The Bristol Stool Form Scale (BSFS): it is adopted to assess bowel habits, with scores from 1 to 7 corresponding to stool types ranging from hardest to softest, where higher scores indicate more severe diarrhea.
Measured: Assessment time points were: baseline (1 week pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS) is an 11-point pain rating scale (0 = no pain, 10 = worst pain). A ≥30% decrease in NRS score indicates clinically significant pain relief.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
The Visceral Sensitivity Index (VSI）
The Visceral Sensitivity Index (VSI): the questionnaire is a 15-item scale used to assess visceral sensitivity. The total score ranges from 0 to 75 points, with higher scores indicating greater visceral sensitivity.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item validated self-rating scale used to screen and assess the severity of depressive symptoms. Each item is rated on a 4-point Likert scale over the past two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. It is widely applied in clinical trials and gastroenterology studies to evaluate emotional comorbidity in IBS patients.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a 7-item validated self-reported questionnaire for screening and quantifying the severity of generalized anxiety symptoms. Participants rate symptom frequency over the preceding two weeks on a 4-point scale. Total scores range from 0 to 21; higher scores represent greater anxiety severity. It is routinely used to evaluate anxiety burden in functional gastrointestinal disorders.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a validated 19-item self-assessment tool evaluating overall sleep quality over the past one month. It covers seven components: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction. The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. It is the gold standard for assessing sleep disturbance in clinical research.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Gut microbiota and metabolites
Gut microbiota refers to the complex community of microorganisms colonizing the human intestinal tract. Their metabolites are bioactive substances produced by microbial fermentation, including short-chain fatty acids, bile acid metabolites, amino acid derivatives and other small-molecule compounds.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment.
Methane-hydrogen breath test
The methane-hydrogen breath test is a non-invasive respiratory detection method used to evaluate small intestinal bacterial overgrowth (SIBO) and intestinal transit function. It detects exhaled hydrogen and methane gas produced by intestinal microbial fermentation.
Measured: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Dec 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Li, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581756
- Sponsor's protocol ID
- 2025-776-01YJ
- Other IDs
- BE2023710, 82470573
- Acronym
- rTMS
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Transcranial Magnetic Stimulation (rTMS) for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07581756
- Acronym / sponsor ID
- rTMS / 2025-776-01YJ
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS), Chronic Diarrhea, Intestinal Flora
- Keywords
- Irritable Bowel Syndrome with diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 May 2026 (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.
Objectives: This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), and to explore the potential underlying mechanisms by which rTMS alleviates clinical symptoms in IBS-D patients.
Design: This is a clinical trial that uses clinical symptom scales to assess the therapeutic effect of rTMS on IBS-D patients. Meanwhile, gut microbiota and metabolite profiling, as well as the methane-hydrogen breath test, will be applied to investigate the mechanism of action from the perspectives of gut microecology, intestinal motility, and metabolism, so as to provide scientific evidence for the clinical application of rTMS in the treatment of IBS-D.
Detailed description
Background: A large number of studies have demonstrated that repetitive transcranial magnetic stimulation (rTMS) can alleviate chronic pain. Its potential mechanisms include modulating cortical excitability, improving cerebral blood flow and metabolism, regulating neurotransmitters and gene expression, and inducing neuroplasticity. Previous findings indicate that the gut-brain neural circuit involving the insular cortex and anterior cingulate cortex serves as a key pathway regulating chronic visceral pain in irritable bowel syndrome (IBS). Studies have also shown that transcranial magnetic stimulation (TMS) can reduce visceral hypersensitivity in patients with IBS. On this basis, the present study further investigates whether rTMS can improve diarrheal symptoms in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), in order to provide a more reliable and effective therapeutic strategy for clinical practice.
Objectives:
This study aims to evaluate the overall clinical efficacy of rTMS in the treatment of IBS-D, including diarrhea, abdominal pain, quality of life, psychiatric symptoms (anxiety and depression), and sleep disturbance. Meanwhile, the underlying mechanisms of rTMS will be explored using gut microbiota and metabolomic profiling, as well as the methane-hydrogen breath test.
Methods:
This is a clinical trial designed to evaluate the efficacy of rTMS in treating chronic diarrhea in IBS-D patients. A total of 46 IBS-D patients meeting eligibility criteria will be randomly assigned to receive either real rTMS (n=23) or sham rTMS (n=23).
The treatment will last for 3 weeks. The real rTMS group will receive 1 Hz stimulation, 20 minutes per session. The sham rTMS group will receive 0 Hz stimulation (sham condition), 20 minutes per session.
Low-frequency rTMS (1 Hz) will be applied over the medial prefrontal cortex (mPFC) using a magnetic stimulator manufactured by Wuhan IRide Company. Stimulation intensity will be set at 80% of the resting motor threshold (RMT). RMT is defined as the minimal stimulus intensity required to evoke a motor evoked potential (MEP) amplitude of ≥50 μV in at least 5 out of 10 consecutive trials.
The coil will be placed tangentially over the mPFC. Patients will remain seated quietly with minimal head movement during the entire session.For the real rTMS group: 1 Hz frequency, 80% RMT intensity, 1100 pulses per session, with each pulse train lasting 2 seconds, and a total session duration of 20 minutes.For the sham rTMS group: the coil is positioned identically but without effective magnetic stimulation, while pre-recorded sound is played to mimic the acoustic feedback of real rTMS.
Outcome Assessments:
Clinical assessments will include diarrhea, abdominal pain, quality of life, intestinal sensitivity, mood status, and sleep.
Mechanistic evaluations will be performed using gut microbiota and metabolite analysis, combined with methane-hydrogen breath test, to explore the mechanisms underlying rTMS effects on chronic diarrhea in IBS-D patients.
Gut microbiota data will be analyzed to compare differences between the treatment and control groups before and after intervention. Correlation analyses will be conducted between clinical improvement and changes in microbial and metabolic profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repeated transcranial magnetic stimulation group | Active comparator | Device: rTMS groupThe rTMS group was given 1 Hz/s for 20 minutes for 3 weeks. |
| sham repetitive transcranial magnetic stimulation group | Sham comparator | Device: sham deviceFor the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants had to be between 18- 60 years of age and fulfill the Rome IV criteria for IBS-D. Specifically, patients must have experienced recurrent abdominal pain at least one day per week in the last three months, with symptom onset at least six months prior to diagnosis, associated with defecation or a change in the frequency or form (appearance) of stool. More than 25% of stool episodes be classified as Bristol Stool Form Scale (BSFS) type 6 or 7, and fewer than 25% as type 1 or 2. In addition, patients were required to exhibit moderate to severe symptoms, defined as an Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score greater than 175 (on a 500-point scale). Dietary preferences of all participants included non vegetarian options and participants maintain stable dietary habits for at least one month prior to randomization. Moreover, patients aged over 50 were required to provide documentation of a normal colonoscopy performed within the preceding three years.
Key exclusion criteria (1 listed)
- The exclusion criteria included a completion rate of daily diaries of less than 50% during the screening period, a history of organic gastrointestinal disease, such as inflammatory bowel disease, a history of surgical resection of the GI tract or cholecystectomy, a recent diagnosis of Helicobacter pylori infection within the past 2 years, a history of gluten or lactose intolerance, a history of malignancy, or a history of neurological or psychiatric conditions. Additionally, individuals with severe systemic diseases, including uncontrolled diabetes mellitus, hyperthyroidism, or severe hepatic, renal, or cardiac insufficiency, were excluded. The use of probiotic or prebiotic supplements, antibiotics (including rifaximin), prokinetic or antidiarrheal agents, tricyclic antidepressants, or immunosuppressive therapies was not permitted within 4 wk prior to screening. Prohibited conditions during the study period included pregnancy, lactation, or being within 12 months postpartum. Lastly, participants with severe needle phobia, metal allergies, implanted cardiac pacemakers, or a known allergic diathesis were excluded. All participants provided their voluntary, written, informed consent prior to their inclusion.
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 |
|---|---|---|
| rTMS groupPatients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 3 weeks. | Device | repeated transcranial magnetic stimulation group |
| sham deviceAlso: sham transcranial magnetic stimulationFor the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. | Device | sham repetitive transcranial magnetic stimulation group |
Primary outcome
Composite response rate
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
The primary outcome measure of this study is the composite response rate on Day 14 of treatment; a composite responder is defined as having both a ≥30% reduction in the weekly average of the worst abdominal pain intensity in the past 24 hours compared with baseline and a ≥50% reduction in the weekly number of days with Bristol Stool Form Scale (BSFS) Type 6 or 7 (diarrheal stools) compared with baseline.
10 secondary outcomes
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
Irritable Bowel Syndrome Quality of Life (IBS-QOL)
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
The Bristol Stool Form Scale (BSFS) and Frequency of defecation
Time frame: Assessment time points were: baseline (1 week pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
Numeric Rating Scale (NRS)
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
The Visceral Sensitivity Index (VSI）
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.
Gut microbiota and metabolites
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment.
Methane-hydrogen breath test
Time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.
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 12 May 2026.
- Individual participant dataSharing planned: No
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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 rTMS group in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea (IBS-D), run by The First Affiliated Hospital of Soochow University 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 1 inclusion and 1 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 12 May 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?
Contact Xiuji Kan (15339525666, xiujikan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite response rate (time frame: Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.