IBS (Irritable Bowel Syndrome)rTMSNCT07172139
Transcranial Magnetic Stimulation and Pharmacologic/Probiotic Interventions for Diarrhea-Predominant IBS
A study testing Active rTMS + Pinaverium Bromide and Active rTMS + Bifidobacterium in people with IBS (Irritable Bowel Syndrome), run by Rui Li.
Trial summary
What is the study about? This study is for adults with diarrhea-predominant irritable bowel syndrome (IBS-D) who suffer from chronic visceral pain. We aim to investigate whether combining two different treatment approaches is more effective in alleviating IBS-D symptoms than either treatment alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS (Irritable Bowel Syndrome)
- What is being tested?
- Active rTMS + Pinaverium Bromide and Active rTMS + Bifidobacterium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (I)Age range 18-75 years (either sex) (II)Fulfilling the Rome IV criteria for irritable bowel syndrome diagnosis (III)Bristol stool type 6-7 in >25% and type 1-2 in <25% of bowel movements (IV)Patients experienced Bristol stool type 6 or 7 on ≥4 days with mean abdominal pain score ≥3 during the initial 2-week period
Who cannot join
- (I)Documented organic gastrointestinal pathology; endocrinologic or metabolic diseases with known gastrointestinal motility effects including diabetes mellitus and hyperthyroidism; previous surgical interventions involving abdominal cavity intestinal tract or anal region (II)current use of any medication with documented effects on gastrointestinal motility or secretory function; administration of concurrent therapies or pharmacologic agents capable of confounding treatment efficacy or safety evaluations (III)pregnancy lactation or postpartum status within 12 months (IV)noncompliance with randomized treatment allocation or demonstrated poor adherence tendencies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Transcranial Magnetic Stimulation vs Sham Stimulation Combined With Pinaverium Bromide vs Bifidobacteria in Diarrhea-Predominant Irritable Bowel Syndrome: A 2×2 Factorial Randomized Clinical Trial
What is the study about? This study is for adults with diarrhea-predominant irritable bowel syndrome (IBS-D) who suffer from chronic visceral pain. We aim to investigate whether combining two different treatment approaches is more effective in alleviating IBS-D symptoms than either treatment alone. The first treatment is a non-invasive brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS), while the second treatment involves either an intestinal antispasmodic medication (Pinaverium Bromide) or a probiotic (Bifidobacterium).
What will participants do?
Read more
Participants will be randomly assigned by a computer to one of four groups:
- Group 1: Receive real rTMS sessions + take Pinaverium Bromide pills.
- Group 2: Receive real rTMS sessions + take Bifidobacterium pills.
- Group 3: Receive fake (sham) rTMS sessions + take Pinaverium Bromide pills.
- Group 4: Receive fake (sham) rTMS sessions + take Bifidobacterium pills.
Neither the participant nor the doctor giving the treatments will know which group the participant is in for the rTMS part (this is called "blinding"). The study will involve several weeks of treatment and follow-up visits to track symptoms.
What are the potential benefits and risks? Potential Benefits: Participants may experience a reduction in their abdominal pain, diarrhea, and other IBS symptoms. However, benefit cannot be guaranteed. The information from this study may help other IBS patients in the future.
Potential Risks: rTMS is generally safe but may cause mild headache, scalp discomfort, or lightheadedness. The medications may have side effects like any drug, which will be explained in detail before the study starts.
Why is this study important? This is the first study to test how brain stimulation and gut-focused treatments work together for IBS pain. The results could lead to new and more effective combination therapies for people who don't get enough relief from current treatments.
Read the detailed description
This is a multicenter, randomized, double-blind, sham-controlled, 2x2 factorial trial investigating the efficacy of combining repetitive Transcranial Magnetic Stimulation (rTMS) with gut-directed therapy for chronic visceral pain in diarrhea-predominant irritable bowel syndrome (IBS-D).
Scientific rationale: Current treatments for IBS-D often provide inadequate relief. rTMS, a non-invasive neuromodulation technique, may alleviate pain by restoring cortical excitability and neural plasticity. Its potential synergy with gut-targeted agents (antispasmodic or probiotic) remains unexplored.
Objectives: The primary objective is to determine the interaction effect between rTMS (real vs. sham) and drug (pinaverium bromide vs. bifidobacterium) on the composite response rate at Week 2. Secondary objectives include assessing changes in IBS-SSS, IBS-QoL, PHQ-9 scores, and anorectal manometry parameters.
Methodology: 140 eligible adults will be randomized equally into four groups: (1) real rTMS + pinaverium bromide, (2) real rTMS + bifidobacterium, (3) sham rTMS + pinaverium bromide, (4) sham rTMS + bifidobacterium. Real rTMS will be delivered at 1Hz, 80% MT over the mPFC for 20 minutes daily for 2 weeks. Sham rTMS uses a placebo coil. Pinaverium bromide (50mg tid) and bifidobacterium (500mg bid) will be administered with matched placebos to maintain blinding. Participants, outcome assessors, and statisticians will be blinded to intervention assignments.
Outcomes: The primary outcome is the proportion of participants achieving composite response (≥30% reduction in worst abdominal pain AND ≥50% reduction in days with BSFS 6/7 stools) at Week 2. Secondary outcomes include changes from baseline in IBS-SSS, IBS-QoL, PHQ-9, and manometry measures.
Statistics: A factorial ANOVA will be used to test the main and interaction effects. The primary analysis will follow the intention-to-treat principle.
- Conditions
- IBS (Irritable Bowel Syndrome)
- Being tested
- Active rTMS + Pinaverium Bromide, Active rTMS + Bifidobacterium, Sham Comparator: Sham rTMS + Pinaverium Bromide, Placebo Comparator: Sham rTMS + Bifidobacterium
- Keywords
- Diarrhea-predominant Irritable Bowel Syndrome, repetitive Transcranial Magnetic Stimulation, Pinaverium Bromide, Bifidobacterium, chronic visceral pain
- 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.
Active rTMS + Pinaverium BromideCombination product
A figure-of-eight coil is used to apply active low-frequency (1 Hz) rTMS to the corresponding representation area of the prefrontal cortex (mPFC). The treatment is administered for 20 minutes daily for a total of 2 weeks.
Active rTMS + BifidobacteriumCombination product
Bifidobacterium animalis subsp. lactis BB-12, provided in capsule form. Each capsule contains a minimum of 5 billion colony-forming units (CFU). Administered orally at a dosage of one capsule twice per day, with meals, for a duration of 2 weeks. The product will be stored refrigerated as per manufacturer's instructions.
Sham Comparator: Sham rTMS + Pinaverium BromideCombination product
Pinaverium Bromide 50 mg film-coated tablets. Administered orally at a dosage of 50 mg (one tablet) three times daily, 30 minutes before meals, for a duration of 2 weeks.
Placebo Comparator: Sham rTMS + BifidobacteriumCombination product
Description: Sham stimulation is delivered using a placebo coil that mimics the sound and sensation of active rTMS but does not deliver the full magnetic field. Parameters identical to active arm.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS + Pinaverium Bromide Group | Experimental | Participants in this arm will receive active repetitive Transcranial Magnetic Stimulation (rTMS) sessions and oral Pinaverium Bromide tablets. Receives: Combination Product: Active rTMS + Pinaverium Bromide |
| Active rTMS + Bifidobacterium Group | Experimental | Participants in this group will receive active repetitive Transcranial Magnetic Stimulation (rTMS) sessions and oral Bifidobacterium supplements. Receives: Combination Product: Active rTMS + Bifidobacterium |
| Sham rTMS + Pinaverium Bromide Group | Sham comparator | Pinaverium Bromide 50 mg film-coated tablets. Administered orally at a dosage of 50 mg (one tablet) three times daily, 30 minutes before meals, for a duration of 2 weeks. Receives: Combination Product: Sham Comparator: Sham rTMS + Pinaverium Bromide |
| Sham rTMS + Bifidobacterium Group | Placebo comparator | Each capsule contains a minimum of 5 billion colony-forming units (CFU). Administered orally at a dosage of one capsule twice per day, with meals, for a duration of 2 weeks. The product will be stored refrigerated as per manufacturer's instructions. Receives: Combination Product: Placebo Comparator: Sham rTMS + Bifidobacterium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with composite response
The primary outcome measure is the proportion of patients achieving a composite response at the end of treatment (Week 2), defined as: a reduction of ≥30% from baseline in the average daily worst abdominal pain score, and a reduction of ≥50% in the number of days with at least one stool consistency meeting BSFS type 6 or 7 criteria during Week 2. Abdominal pain intensity is assessed using an 11-point NRS scale (0-10) for the last 24 hours daily. Stool consistency is recorded daily by the patient selecting the most representative category according to the BSFS.
Measured: At Week 2 (end of treatment)
Secondary outcomes (1)
Symptoms, Quality of Life
The IBS Symptom Severity Scale (IBS-SSS) is utilized to assess the overall symptomatology of irritable bowel syndrome. This scale comprises five domains: severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and impact on quality of life. Each domain is scored on a scale from 0 to 100, resulting in a total score range of 0 to 500.A decrease of 50 points is considered as a minimal clinically important diference . Te IBS Quality of Life (IBS-QoL) comprises 34 IBS-specifc items which divide into 8 variables: health worries, food avoidance, body image, dysphoria, interference with activity, social reactions, sexual activity, and relationships. Te IBS-QoL score will be transformed into a 0-100 scale using the following formula: (the actual raw score - the lowest possible score)/possible score range
× 100.
Measured: From baseline to week 2 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS (Irritable Bowel Syndrome)Studies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rui Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rui Li, The First Affiliated Hospital of Soochow University
- Investigators
- Rui Li, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172139
- Sponsor's protocol ID
- 2025655
- Acronym
- rTMS
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Magnetic Stimulation vs Sham Stimulation Combined With Pinaverium Bromide vs Bifidobacteria in Diarrhea-Predominant Irritable Bowel Syndrome: A 2×2 Factorial Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07172139
- Acronym / sponsor ID
- rTMS / 2025655
- Conditions
- IBS (Irritable Bowel Syndrome)
- Keywords
- Diarrhea-predominant Irritable Bowel Syndrome, repetitive Transcranial Magnetic Stimulation, Pinaverium Bromide, Bifidobacterium, chronic visceral pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Rui LiUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Sep 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.
What is the study about? This study is for adults with diarrhea-predominant irritable bowel syndrome (IBS-D) who suffer from chronic visceral pain. We aim to investigate whether combining two different treatment approaches is more effective in alleviating IBS-D symptoms than either treatment alone. The first treatment is a non-invasive brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS), while the second treatment involves either an intestinal antispasmodic medication (Pinaverium Bromide) or a probiotic (Bifidobacterium).
What will participants do?
Participants will be randomly assigned by a computer to one of four groups:
- Group 1: Receive real rTMS sessions + take Pinaverium Bromide pills.
- Group 2: Receive real rTMS sessions + take Bifidobacterium pills.
- Group 3: Receive fake (sham) rTMS sessions + take Pinaverium Bromide pills.
- Group 4: Receive fake (sham) rTMS sessions + take Bifidobacterium pills.
Neither the participant nor the doctor giving the treatments will know which group the participant is in for the rTMS part (this is called "blinding"). The study will involve several weeks of treatment and follow-up visits to track symptoms.
What are the potential benefits and risks? Potential Benefits: Participants may experience a reduction in their abdominal pain, diarrhea, and other IBS symptoms. However, benefit cannot be guaranteed. The information from this study may help other IBS patients in the future.
Potential Risks: rTMS is generally safe but may cause mild headache, scalp discomfort, or lightheadedness. The medications may have side effects like any drug, which will be explained in detail before the study starts.
Why is this study important? This is the first study to test how brain stimulation and gut-focused treatments work together for IBS pain. The results could lead to new and more effective combination therapies for people who don't get enough relief from current treatments.
Detailed description
This is a multicenter, randomized, double-blind, sham-controlled, 2x2 factorial trial investigating the efficacy of combining repetitive Transcranial Magnetic Stimulation (rTMS) with gut-directed therapy for chronic visceral pain in diarrhea-predominant irritable bowel syndrome (IBS-D).
Scientific rationale: Current treatments for IBS-D often provide inadequate relief. rTMS, a non-invasive neuromodulation technique, may alleviate pain by restoring cortical excitability and neural plasticity. Its potential synergy with gut-targeted agents (antispasmodic or probiotic) remains unexplored.
Objectives: The primary objective is to determine the interaction effect between rTMS (real vs. sham) and drug (pinaverium bromide vs. bifidobacterium) on the composite response rate at Week 2. Secondary objectives include assessing changes in IBS-SSS, IBS-QoL, PHQ-9 scores, and anorectal manometry parameters.
Methodology: 140 eligible adults will be randomized equally into four groups: (1) real rTMS + pinaverium bromide, (2) real rTMS + bifidobacterium, (3) sham rTMS + pinaverium bromide, (4) sham rTMS + bifidobacterium. Real rTMS will be delivered at 1Hz, 80% MT over the mPFC for 20 minutes daily for 2 weeks. Sham rTMS uses a placebo coil. Pinaverium bromide (50mg tid) and bifidobacterium (500mg bid) will be administered with matched placebos to maintain blinding. Participants, outcome assessors, and statisticians will be blinded to intervention assignments.
Outcomes: The primary outcome is the proportion of participants achieving composite response (≥30% reduction in worst abdominal pain AND ≥50% reduction in days with BSFS 6/7 stools) at Week 2. Secondary outcomes include changes from baseline in IBS-SSS, IBS-QoL, PHQ-9, and manometry measures.
Statistics: A factorial ANOVA will be used to test the main and interaction effects. The primary analysis will follow the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active rTMS + Pinaverium Bromide Group | Experimental | Combination Product: Active rTMS + Pinaverium BromideParticipants in this arm will receive active repetitive Transcranial Magnetic Stimulation (rTMS) sessions and oral Pinaverium Bromide tablets. |
| Active rTMS + Bifidobacterium Group | Experimental | Combination Product: Active rTMS + BifidobacteriumParticipants in this group will receive active repetitive Transcranial Magnetic Stimulation (rTMS) sessions and oral Bifidobacterium supplements. |
| Sham rTMS + Pinaverium Bromide Group | Sham comparator | Combination Product: Sham Comparator: Sham rTMS + Pinaverium BromidePinaverium Bromide 50 mg film-coated tablets. Administered orally at a dosage of 50 mg (one tablet) three times daily, 30 minutes before meals, for a duration of 2 weeks. |
| Sham rTMS + Bifidobacterium Group | Placebo comparator | Combination Product: Placebo Comparator: Sham rTMS + BifidobacteriumEach capsule contains a minimum of 5 billion colony-forming units (CFU). Administered orally at a dosage of one capsule twice per day, with meals, for a duration of 2 weeks. The product will be stored refrigerated as per manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (I)Age range 18-75 years (either sex) (II)Fulfilling the Rome IV criteria for irritable bowel syndrome diagnosis (III)Bristol stool type 6-7 in >25% and type 1-2 in <25% of bowel movements (IV)Patients experienced Bristol stool type 6 or 7 on ≥4 days with mean abdominal pain score ≥3 during the initial 2-week period
Key exclusion criteria (1 listed)
- (I)Documented organic gastrointestinal pathology; endocrinologic or metabolic diseases with known gastrointestinal motility effects including diabetes mellitus and hyperthyroidism; previous surgical interventions involving abdominal cavity intestinal tract or anal region (II)current use of any medication with documented effects on gastrointestinal motility or secretory function; administration of concurrent therapies or pharmacologic agents capable of confounding treatment efficacy or safety evaluations (III)pregnancy lactation or postpartum status within 12 months (IV)noncompliance with randomized treatment allocation or demonstrated poor adherence tendencies
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 |
|---|---|---|
| Active rTMS + Pinaverium BromideA figure-of-eight coil is used to apply active low-frequency (1 Hz) rTMS to the corresponding representation area of the prefrontal cortex (mPFC). The treatment is administered for 20 minutes daily for a total of 2 weeks. | Combination product | Active rTMS + Pinaverium Bromide Group |
| Active rTMS + BifidobacteriumBifidobacterium animalis subsp. lactis BB-12, provided in capsule form. Each capsule contains a minimum of 5 billion colony-forming units (CFU). Administered orally at a dosage of one capsule twice per day, with meals, for a duration of 2 weeks. The product will be stored refrigerated as per manufacturer's instructions. | Combination product | Active rTMS + Bifidobacterium Group |
| Sham Comparator: Sham rTMS + Pinaverium BromidePinaverium Bromide 50 mg film-coated tablets. Administered orally at a dosage of 50 mg (one tablet) three times daily, 30 minutes before meals, for a duration of 2 weeks. | Combination product | Sham rTMS + Pinaverium Bromide Group |
| Placebo Comparator: Sham rTMS + BifidobacteriumDescription: Sham stimulation is delivered using a placebo coil that mimics the sound and sensation of active rTMS but does not deliver the full magnetic field. Parameters identical to active arm. | Combination product | Sham rTMS + Bifidobacterium Group |
Primary outcome
Proportion of participants with composite response
Time frame: At Week 2 (end of treatment)
The primary outcome measure is the proportion of patients achieving a composite response at the end of treatment (Week 2), defined as: a reduction of ≥30% from baseline in the average daily worst abdominal pain score, and a reduction of ≥50% in the number of days with at least one stool consistency meeting BSFS type 6 or 7 criteria during Week 2. Abdominal pain intensity is assessed using an 11-point NRS scale (0-10) for the last 24 hours daily. Stool consistency is recorded daily by the patient selecting the most representative category according to the BSFS.
1 secondary outcome
Symptoms, Quality of Life
Time frame: From baseline to week 2 of 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 15 Sep 2025.
- 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.
Rui Li principal investigator
The First Affiliated Hospital of Soochow University
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS + Pinaverium Bromide and Active rTMS + Bifidobacterium in people with IBS (Irritable Bowel Syndrome), run by Rui Li.
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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Rui Li, PhD (+86 13771725877, lrhcsz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with composite response (time frame: At Week 2 (end of 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 15 Sep 2025.