Electro-acupuncture for Irritable Bowel Syndrome With Constipation

NCT06219707 | Completed

• 1 other identifier: IRB-2023-451
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome With Constipation

Keywords

Acupuncture; Irritable Bowel Syndrome with Constipation; Microbiota

Outcome Measures

Primary Outcomes (1)

• Responders have a decrease in the weekly average of worst abdominal pain scores of ≥30% compared with baseline and a weekly increase of ≥1 CSBM

  Proportion of patients with a decrease in the weekly average of worst abdominal pain scores of ≥30% and a weekly increase of ≥1 CSBM as compared with the baseline.

  Baseline (week 2), after treatment period (week 8), end of follow-up (week 14)

Secondary Outcomes (26)

• Proportion of patients with an improvement of ≥30% in abdominal pain scores

  Baseline, week 8, week 14

• Proportion of patients with an average increase of 1 or more spontaneous, complete bowel movements per week

  Baseline, week 8, week 14

• Average number of spontaneous bowel movements, complete spontaneous bowel movements per week

  Baseline, week 8, week 14

• Percentage of bowel movements with normal consistency

  Baseline, week 8, week 14

• Percentage of bowel movements with severe or very severe straining during defecation

  Baseline, week 8, week 14

Study Arms (2)

Electro-Acupuncture group

EXPERIMENTAL

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.

Device: Acupuncture needles

Sham-Acupuncture group

SHAM COMPARATOR

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.

Device: Acupuncture needles

Interventions

Acupuncture needles DEVICE

The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.

Electro-Acupuncture group; Sham-Acupuncture group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or breast-feeding;
• Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases;
• History of gastrointestinal tract segment removal or bariatric surgery for obesity;
• Appendectomy or cholecystectomy within the past 2 months, or other abdominal surgeries within the past 6 months prior to trial enrollment;
• Unstable medical conditions that could be associated with abdominal pain or discomfort and could potentially influence the assessments in this trial (e.g., chronic kidney disease, endometriosis, lactose intolerance);
• Diagnosed with primary severe mental illness;
• Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic;
• Alcoholism or drug abuse in past 1 year;
• Having needle phobia or allergy to acupuncture needle materials;
• Antibiotics and probiotics/prebiotics usage in the previous month;
• Participating in other clinical studies.

Sponsors & Collaborators

• Nanyang Technological University: lead
• National University of Singapore: collaborator

Study Sites (1)

Nanyang Technological University, School of Biological Sciences

Singapore, Singapore, 637551, Singapore

Location

Related Publications (5)

• Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci. 2003 Jan;26(1):17-22. doi: 10.1016/s0166-2236(02)00006-1. No abstract available.

  PMID: 12495858 BACKGROUND

• Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.

  PMID: 27618593 BACKGROUND

• Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670.

  PMID: 18509121 BACKGROUND

• Schmulson MJ, Drossman DA. What Is New in Rome IV. J Neurogastroenterol Motil. 2017 Apr 30;23(2):151-163. doi: 10.5056/jnm16214.

  PMID: 28274109 BACKGROUND

• Lam WC, Chen H, Siah KTH, Thakur ER, Zhong LLD. Electro-acupuncture for irritable bowel syndrome with constipation: study protocol of a pilot, randomized, double-blinded, sham-controlled trial. Front Neurol. 2025 Sep 12;16:1632822. doi: 10.3389/fneur.2025.1632822. eCollection 2025.

  PMID: 41018183 DERIVED

Study Officials

• Linda LD Zhong, PhD

  Nanyang Technological University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After a participant's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist. The clinical assessor and participants will be blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: Each patient will be scheduled for a total of 12 treatment sessions, 30 minutes for each session, 2 times a week over 6-week period.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: September 12, 2024
• Primary Completion: May 21, 2026
• Study Completion: May 21, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available within 7 years after completion of the clinical trial.
• Access Criteria: Individual participant data (IPD) will be made available to qualified researchers upon request. To access the data, researchers must submit a formal request, which will be reviewed and approved by the data sharing committee. Data access will be granted for research purposes only and will require adherence to data use agreements and ethics guidelines.

Locations

SG (1)