Transcranial Magnetic Stimulation and Pharmacologic/Probiotic Interventions for Diarrhea-Predominant IBS

NCT07172139 | Not Yet Recruiting DMC

• 1 other identifier: 2025655
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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. 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:

1. 1.Group 1: Receive real rTMS sessions + take Pinaverium Bromide pills.
2. 2.Group 2: Receive real rTMS sessions + take Bifidobacterium pills.
3. 3.Group 3: Receive fake (sham) rTMS sessions + take Pinaverium Bromide pills.
4. 4.Group 4: Receive fake (sham) rTMS sessions + take Bifidobacterium pills.

Conditions

IBS (Irritable Bowel Syndrome)

Keywords

Diarrhea-predominant Irritable Bowel Syndrome; repetitive Transcranial Magnetic Stimulation; Pinaverium Bromide; Bifidobacterium; chronic visceral pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At Week 2 (end of treatment)

Secondary Outcomes (1)

• Symptoms, Quality of Life

  From baseline to week 2 of treatment

Study Arms (4)

Active rTMS + Pinaverium Bromide Group

EXPERIMENTAL

Participants in this arm will receive active repetitive Transcranial Magnetic Stimulation (rTMS) sessions and oral Pinaverium Bromide tablets.

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.

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.

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.

Combination Product: Placebo Comparator: Sham rTMS + Bifidobacterium

Interventions

Active rTMS + Pinaverium Bromide COMBINATION_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 + Pinaverium Bromide Group

Active rTMS + Bifidobacterium COMBINATION_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.

Active rTMS + Bifidobacterium Group

Sham Comparator: Sham rTMS + Pinaverium Bromide COMBINATION_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.

Sham rTMS + Pinaverium Bromide Group

Placebo Comparator: Sham rTMS + Bifidobacterium COMBINATION_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.

Sham rTMS + Bifidobacterium Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Rui Li: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

pinaverium

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Rui Li

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Li, PhD

CONTACT

+86 13771725877; lrhcsz@163.com

Ruixia Weng, M.D.

CONTACT

+86 15206214921; 20227832021@stu.suda.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent researcher will generate a randomized sequence using an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists) with 1:1:1:1 allocation stratified by center. The attending physician will open sealed envelopes before treatment to assign participants to one of four groups: rTMS with pinaverium, rTMS with Bifidobacterium, sham with pinaverium, or sham with Bifidobacterium. Block randomization (block size=4) ensures balance across centers. For blinding, identical capsules conceal medications from patients and outcome assessors. Participants are blinded to real/sham rTMS due to identical auditory cues. rTMS operators are unblinded but excluded from outcome assessment. All other personnel remain blinded.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Soochow University

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share