Irritable Bowel SyndromePhase 1NCT06960369
Efficacy of Repeated Transcranial Magnetic Stimulation Combined With a Live Probiotic Tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
A Phase 1 study testing rTMS combined with Live Probiotic tablet 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
To evaluate the overall efficacy of repeated Transcranial Magnetic Stimulation(rTMS) combined with a Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) Methods: Clinical efficacy evaluation of TMS… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- 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 combined with Live Probiotic tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Jun 2026
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.
- Age range between 18-70 years.
- The duration of the disease is more than 6 months.
- There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms.
- The IBS symptom severity score at baseline must not be less than 75.
- No pharmacological treatment (excluding emergency treatment) for IBS for at least 2 weeks prior to the start of treatment; no concurrent participation in other clinical programs.
- Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project.
Who cannot join
- Be less than 18 years old or more than 70 years old.
- Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function.
- Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the digestive tract dynamics; patients who have had a history of surgery on the anus and intestines or the abdomen.
- The presence of the following conditions affecting the efficacy or safety judgment: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② treatment with other treatments and drugs that may affect the results of the judgment.
- Those who are pregnant, breastfeeding or less than 12 months after delivery.
- Patients with severe fear of needles, metal allergies or sensitivities, or those with pacemakers.
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- Patients who do not comply with the randomized assignment to the treatment group or have a tendency to be unstable such as poor compliance.
- Patients who are participating in other research projects.
- Those who do not want to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rui Li, Dr contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Wu Shuangjie, +8651267972743, sdfyec@163.com
About this study
To evaluate the overall efficacy of repeated Transcranial Magnetic Stimulation(rTMS) combined with a Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Methods:
Read more
Clinical efficacy evaluation of TMS combined with Live Probiotic tablet for chronic diarrhea in IBS patients. The 400 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live), rTMS combined placebo, shamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) and shamrTMS combined placebo group. Corresponding treatment was given for 2 week, rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Clinical assessment included symptoms, stool traits, mood, and sleep.
- Study on the mechanism of using intestinal flora data to evaluate the treatment of chronic diarrhea in IBS patients. 30 cases each were included in the 4 groups of IBS-eligible patients, and repeated transcranial magnetic stimulation treatment was given to the patient group for 2 week, and the patient group underwent the assessment of investigating the quantity and metabolic changes of the intestinal flora in feces before and after the treatment.
Read the detailed description
A large number of literature has reported that repetitive transcranial magnetic stimulation(rTMS) can relieve chronic pain. The specific mechanisms include that rTMS can change the excitability of the cerebral cortex, improve cerebral blood flow and metabolism, regulate neurotransmitter and gene expression, and plastic changes in the nervous system.Previous research results revealed that the neural circuit of the cuticular nucleus - anterior cingulate cortex is a unique neural circuit regulating chronic visceral pain in the IBS animal model. To explore the improvement of chronic visceral pain sensitivity in patients with irritable bowel syndrome (IBS) by Transcranial magnetic stimulation (TMS). On this basis, To further explore whether repetitive transcranial magnetic stimulation can treat the diarrhea symptoms of patients with irritable bowel syndrome, and to provide a more reliable and effective treatment method for clinical application.
Objective:
To evaluate the overall efficacy of repeated Transcranial Magnetic Stimulation(rTMS) Combined with a Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D), including abdominal diarrhea symptoms,bowel symptoms, and psychiatric symptoms (anxiety, depression, sleep disturbance). And also to explore the mechanism of rTMS combined with Live Probiotic tablet for the treatment of IBS-D, based on intestinal flora data.
Methods:
Clinical efficacy evaluation of TMS combined with Live Probiotic tablet for chronic diarrhea in IBS patients. The 400 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live), rTMS combined placebo, shamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) and shamrTMS combined placebo group. Corresponding treatment was given for 2 week, rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Clinical assessment included symptoms, stool traits, mood, and sleep.
- Study on the mechanism of using intestinal flora data to evaluate the treatment of chronic diarrhea in IBS patients. 30 cases each were included in the 4 groups of IBS-eligible patients, and repeated transcranial magnetic stimulation treatment was given to the patient group for 2 week, and the patient group underwent the assessment of investigating the quantity and metabolic changes of the intestinal flora in feces before and after the treatment.
The intestinal flora data of the four groups were analyzed to compare the differences between the treatment groups and control group before and after treatment and the improvement values of the clinical observation indexes were correlated.
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS), Probiotic, Chronic Diarrhea, Intestinal Flora
- Being tested
- rTMS combined with Live Probiotic tablet, rTMS combined placebo, shamrTMS combined with Live Probiotic tablet, shamrTMS combined placebo group
- Keywords
- Irritable Bowel Syndrome with diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS), Probiotic
- 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 combined with Live Probiotic tabletCombination product
rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week.
rTMS combined placeboDevice
rTMS group received 1 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week.
shamrTMS combined with Live Probiotic tabletDrug
Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week.
shamrTMS combined placebo groupOther
shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week.
| Study group | Role | What they receive |
|---|---|---|
| rTMS combined with Live Probiotic tablet | Experimental | rTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live).
rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week. Receives: Combination Product: rTMS combined with Live Probiotic tablet |
| rTMS combined placebo | Experimental | rTMS combined placebo
rTMS group received 1 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Receives: Device: rTMS combined placebo |
| shamrTMS combined with Live Probiotic tablet | Experimental | shamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live)
Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week. Receives: Drug: shamrTMS combined with Live Probiotic tablet |
| shamrTMS combined placebo group | Other | shamrTMS combined placebo group
shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Receives: Other: shamrTMS combined placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of defecation and Bristol Stool Form Scale score
The therapeutic effect was evaluated by recording the frequency of defecation and the state of feces of the patients before and after treatment.
The Bristol Stool Form Scale is to standardize the classification of stool consistency and form.
- Types 1-2: Hard, lumpy stools (associated with constipation).
- Types 3-4: Loose or smooth stools (ideal consistency).
- Types 5-7: Watery, mushy, or liquid stools (linked to diarrhea). The Bristol Stool Form Scale (BSFS) is for monitoring treatment responses to interventions.
Measured: One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
Secondary outcomes (1)
IBS-symptom severity score
The criteria were based on the IBS Symptom Severity Score (IBS-SSS), a hierarchical efficacy assessment method.The IBS-SSS consists of five entries assessing the degree of abdominal pain and discomfort, frequency of abdominal pain episodes, the degree of abdominal distension and discomfort, the degree of satisfaction with bowel habits and behaviors, and the degree of impact of intestinal symptoms on life,with a total score of 500 points. A score of 75-175 is considered mild, 176-300 is moderate, and over 300 is severe. Cure was defined as a total IBS symptom severity of less than 75; efficacy was defined as 2-level improvement in total score(e.g., symptoms improved from severe to mild); validity was defined as a 1-level improvement in tatal(e.g., symptoms improved from severe to moderate or symptoms from moderate to mild); and invalidity was defined as no improvement or deterioration in total score.
Measured: One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Dec 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow University
- Responsible party
- Principal investigator, Rui Li, The First Affiliated Hospital of Soochow University
- Investigators
- Rui Li, Principal investigator, Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960369
- Sponsor's protocol ID
- 2024518
- Status last verified
- May 2025
- First submitted
- 19 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repeated Transcranial Magnetic Stimulation Combined With a Live Probiotic Tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT06960369
- Acronym / sponsor ID
- 2024518
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS), Probiotic, Chronic Diarrhea, Intestinal Flora
- Keywords
- Irritable Bowel Syndrome with diarrhea (IBS-D), Repetitive Transcranial Magnetic Stimulation (rTMS), Probiotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Soochow University
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 May 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 evaluate the overall efficacy of repeated Transcranial Magnetic Stimulation(rTMS) combined with a Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Methods:
Clinical efficacy evaluation of TMS combined with Live Probiotic tablet for chronic diarrhea in IBS patients. The 400 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live), rTMS combined placebo, shamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) and shamrTMS combined placebo group. Corresponding treatment was given for 2 week, rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Clinical assessment included symptoms, stool traits, mood, and sleep.
- Study on the mechanism of using intestinal flora data to evaluate the treatment of chronic diarrhea in IBS patients. 30 cases each were included in the 4 groups of IBS-eligible patients, and repeated transcranial magnetic stimulation treatment was given to the patient group for 2 week, and the patient group underwent the assessment of investigating the quantity and metabolic changes of the intestinal flora in feces before and after the treatment.
Detailed description
A large number of literature has reported that repetitive transcranial magnetic stimulation(rTMS) can relieve chronic pain. The specific mechanisms include that rTMS can change the excitability of the cerebral cortex, improve cerebral blood flow and metabolism, regulate neurotransmitter and gene expression, and plastic changes in the nervous system.Previous research results revealed that the neural circuit of the cuticular nucleus - anterior cingulate cortex is a unique neural circuit regulating chronic visceral pain in the IBS animal model. To explore the improvement of chronic visceral pain sensitivity in patients with irritable bowel syndrome (IBS) by Transcranial magnetic stimulation (TMS). On this basis, To further explore whether repetitive transcranial magnetic stimulation can treat the diarrhea symptoms of patients with irritable bowel syndrome, and to provide a more reliable and effective treatment method for clinical application.
Objective:
To evaluate the overall efficacy of repeated Transcranial Magnetic Stimulation(rTMS) Combined with a Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D), including abdominal diarrhea symptoms,bowel symptoms, and psychiatric symptoms (anxiety, depression, sleep disturbance). And also to explore the mechanism of rTMS combined with Live Probiotic tablet for the treatment of IBS-D, based on intestinal flora data.
Methods:
Clinical efficacy evaluation of TMS combined with Live Probiotic tablet for chronic diarrhea in IBS patients. The 400 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live), rTMS combined placebo, shamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) and shamrTMS combined placebo group. Corresponding treatment was given for 2 week, rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Clinical assessment included symptoms, stool traits, mood, and sleep.
- Study on the mechanism of using intestinal flora data to evaluate the treatment of chronic diarrhea in IBS patients. 30 cases each were included in the 4 groups of IBS-eligible patients, and repeated transcranial magnetic stimulation treatment was given to the patient group for 2 week, and the patient group underwent the assessment of investigating the quantity and metabolic changes of the intestinal flora in feces before and after the treatment.
The intestinal flora data of the four groups were analyzed to compare the differences between the treatment groups and control group before and after treatment and the improvement values of the clinical observation indexes were correlated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rTMS combined with Live Probiotic tablet | Experimental | Combination Product: rTMS combined with Live Probiotic tabletrTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live). rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week. |
| rTMS combined placebo | Experimental | Device: rTMS combined placeborTMS combined placebo rTMS group received 1 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. |
| shamrTMS combined with Live Probiotic tablet | Experimental | Drug: shamrTMS combined with Live Probiotic tabletshamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week. |
| shamrTMS combined placebo group | Other | Other: shamrTMS combined placebo groupshamrTMS combined placebo group shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.
- Age range between 18-70 years.
- The duration of the disease is more than 6 months.
- There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms.
- The IBS symptom severity score at baseline must not be less than 75.
Key exclusion criteria (9 listed)
- Be less than 18 years old or more than 70 years old.
- Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function.
- Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the digestive tract dynamics; patients who have had a history of surgery on the anus and intestines or the abdomen.
- The presence of the following conditions affecting the efficacy or safety judgment: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② treatment with other treatments and drugs that may affect the results of the judgment.
- Those who are pregnant, breastfeeding or less than 12 months after delivery.
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 combined with Live Probiotic tabletrTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week. | Combination product | rTMS combined with Live Probiotic tablet |
| rTMS combined placeborTMS group received 1 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. | Device | rTMS combined placebo |
| shamrTMS combined with Live Probiotic tabletLive Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week. | Drug | shamrTMS combined with Live Probiotic tablet |
| shamrTMS combined placebo groupshamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. | Other | shamrTMS combined placebo group |
Primary outcome
Frequency of defecation and Bristol Stool Form Scale score
Time frame: One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
The therapeutic effect was evaluated by recording the frequency of defecation and the state of feces of the patients before and after treatment. The Bristol Stool Form Scale is to standardize the classification of stool consistency and form. * Types 1-2: Hard, lumpy stools (associated with constipation). * Types 3-4: Loose or smooth stools (ideal consistency). * Types 5-7: Watery, mushy, or liquid stools (linked to diarrhea). The Bristol Stool Form Scale (BSFS) is for monitoring treatment responses to interventions.
1 secondary outcome
IBS-symptom severity score
Time frame: One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
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 7 May 2025.
- Individual participant dataSharing planned: No. This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.
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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.
Rui Li, Dr contact
Rui Li principal investigator
Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rTMS combined with Live Probiotic tablet 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 7 inclusion and 9 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 7 May 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+86 153 3952 5666, xiujikan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of defecation and Bristol Stool Form Scale score (time frame: One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment). 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 7 May 2025.