Status:
NOT_YET_RECRUITING
Transcranial Magnetic Stimulation and Pharmacologic/Probiotic Interventions for Diarrhea-Predominant IBS
Lead Sponsor:
Rui Li
Conditions:
IBS (Irritable Bowel Syndrome)
Eligibility:
All Genders
18-75 years
Phase:
NA
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 differen...
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 ther...
Eligibility Criteria
Inclusion
- (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
- (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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07172139
Start Date
September 1 2025
End Date
May 1 2026
Last Update
September 15 2025
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