Study protocol for a prospective, investigator-initiated clinical trial on the vascular effects of acupuncture in the abdomen and lower limbs for patients with diarrhea-predominant irritable bowel syndrome

Int J Colorectal Dis. 2025 Apr 25;40(1):103. doi: 10.1007/s00384-025-04868-z.

Abstract

Background: Physicians classify irritable bowel syndrome with diarrhea symptoms under the label IBS-D which represents a gastrointestinal disorder that meets specific functional diagnostic criteria. Studies show acupuncture helps manage IBS-D symptoms though researchers do not understand if specific treatment points in the abdomen provide better outcomes than standard acupuncture points in the lower body regions. The study investigates the effects acupuncture treatments using local and systemic needling techniques have on IBS-D symptom expression and gut microbial diversity features.

Methods: The study employs a randomized controlled single-blinded exploratory clinical trial design which includes 36 participants diagnosed with IBS-D via Rome IV criteria. Participants are randomly allocated to one of three groups: abdominal acupuncture, lower limb acupuncture, or standard treatment. Participants who receive acupuncture treatment receive eight sessions which are distributed throughout 4 weeks as clinicians activate specific points connected to gastrointestinal function. Lifestyle education and approved medications with symptom management make up the standard treatment provided to participants. The main outcome measures assess IBS Symptom Severity Scale (IBS-SSS) score changes from baseline at Week 5. Additional evaluation measures in this study comprise stool consistency examination alongside patient global assessments and cold-heat surveys along with EQ-5D-5L quality of life assessment and gut microbiota examination as secondary outcomes.

Results: Research has been designed to evaluate how abdominal and lower limb acupuncture techniques compare in symptom relief and microbiota adaptation outcomes. The preliminary data is expected to reveal distinct patterns between local and wide-reaching effects which suggests that IBS-D treatment should be tailored on a personal basis.

Conclusion: The comparison of abdominal and lower limb acupuncture treatment efficacy adds to our understanding of acupuncture therapy benefit for IBS-D. The results will help guide clinical practice and support the creation of tailored acupuncture treatments.

Keywords: Abdominal acupoints; Acupuncture; Clinical trial; Gut microbiota; IBS-D; Lower limb acupoints; Personalized protocols; Symptom relief.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Abdomen* / blood supply
  • Acupuncture Therapy*
  • Adult
  • Diarrhea* / complications
  • Diarrhea* / microbiology
  • Diarrhea* / physiopathology
  • Diarrhea* / therapy
  • Female
  • Gastrointestinal Microbiome
  • Humans
  • Irritable Bowel Syndrome* / complications
  • Irritable Bowel Syndrome* / microbiology
  • Irritable Bowel Syndrome* / physiopathology
  • Irritable Bowel Syndrome* / therapy
  • Lower Extremity* / blood supply
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Treatment Outcome