Electro-acupuncture for Irritable Bowel Syndrome With Constipation: a Pilot, Randomized, Double-blinded, Sham-controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of the clinical trial is to evaluate the efficacy and safety of electro-acupuncture for irritable bowel syndrome with constipation (IBS-C) patients. 60 IBS-C patients will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm. We hypothesize that electro-acupuncture would result in superior symptom improvement compared to sham acupuncture. In addition, biological samples (blood, urine, and stool) will be collected during the trial for future exploratory studies. These samples will be used to investigate changes in gut microbiota composition and related metabolites. These analyses aim to explore potential mechanistic links between electro-acupuncture interventions and clinical outcomes in subsequent research. Apart from the IBS-C participants, 30 healthy volunteers aged 21 to 65 years (inclusive) will be recruited to provide blood, urine, and stool samples. These samples will serve as a reference for comparative analyses with those from IBS-C patients before and after electro-acupuncture treatment. The healthy controls will not receive any interventions.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: t
View:
• Fulfilment of the Rome IV criteria for IBS-C;
• Age of 21 to 65 years (inclusive);
• Weekly average of worst daily abdominal pain score of ≥3 (0-10 scale) for at least 12 weeks before the first visit and during screening period;
• \<3 complete spontaneous bowel movements (CSBMs) per week for at least 12 weeks before the first visit and during screening period;
• Written informed consent.
Locations
Other Locations
Singapore
Nanyang Technological University, School of Biological Sciences
RECRUITING
Singapore
Contact Information
Primary
Linda LD Zhong, MD., PhD
linda.zhong@ntu.edu.sg
(+65) 67911744
Backup
Wai Ching Lam, MPH
waiching001@e.ntu.edu.sg
(+65) 67911744
Time Frame
Start Date:2024-09-12
Estimated Completion Date:2025-12-01
Participants
Target number of participants:60
Treatments
Experimental: Electro-Acupuncture group
Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable. The alternating stimulation is believed to produce maximal biochemical responses in the brain.
Sham_comparator: Sham-Acupuncture group
Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted (actual penetration of the skin) at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli. The sham points aren't acupuncture points nor located on meridians. Both the electroacupuncture and sham acupuncture groups follow the same procedures, including connection to the stimulator device for the same duration. In the sham group, although no electrical current is delivered, the power switch is turned on and the knobs are manipulated to produce audible clicking sounds, mimicking auditory cues of active treatment.