NCT Number: NCT07172139
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. Group 1: Receive real rTMS sessions + take Pinaverium Bromide pills. 2. Group 2: Receive real rTMS sessions + take Bifidobacterium pills. 3. Group 3: Receive fake (sham) rTMS sessions + take Pinaverium Bromide pills. 4. 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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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
Exclusion criteria
(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
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.
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.
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.
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.
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.
Time frame: From baseline to week 2 of treatment
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.
Contact information is provided by the study sponsor or research team.
Rui Li, PhD
CONTACT
Ruixia Weng, M.D.
CONTACT
Rui Li
Other
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
Acronym: rTMS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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