Comparing manual and electroacupuncture for functional constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, parallel-group trial will enroll 72 adults with functional constipation and randomize them 1:1 to manual acupuncture or electroacupuncture. Both groups receive 30-minute sessions at bilateral ST25 and ST37 three times per week for 12 weeks, while the electroacupuncture group receives additional continuous electrical stimulation (10 Hz, 0.5–4 mA). The primary outcome is the responder rate at week 12, defined as the percentage achieving ≥3 complete spontaneous bowel movements per week. Secondary outcomes include changes in gut microbiota, brain functional connectivity measured by multimodal MRI and fNIRS, and patient-reported symptom scales.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meet Rome IV diagnostic criteria for functional constipation
* Symptoms present for ≥6 months, meeting diagnostic criteria in the last 3 months
* Mean weekly complete spontaneous bowel movements (CSBMs) ≤2 during 14-day baseline period
* Age 18-75 years
* No use of constipation medications for at least 2 weeks prior to treatment (except rescue medication)
* No acupuncture treatment for constipation in the past 3 months
* Not currently participating in another clinical trial
* Willing and able to provide written informed consent

Exclusion Criteria:

* Constipation secondary to other causes (IBS, organic diseases, medications, endocrine disorders, metabolic disorders, neurological disorders, or gastrointestinal surgery)
* Loose or watery stools (Bristol type 6 or 7) \>1 time during baseline without laxative use
* History of pelvic floor dysfunction
* Use of probiotics, fiber supplements, or laxatives within 2 weeks prior to treatment (2-week washout required)
* Severe hemorrhoids or anal fissures
* Severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; hepatosplenomegaly; cognitive impairment; or psychiatric disorders
* Dependence on opioids or anticholinergic drugs
* Red flags: unexplained weight loss \>10% in 3 months, hematochezia or positive fecal occult blood, family history of colon cancer (first-degree relative diagnosed \<50 years), anemia (Hb \<110 g/L), or elevated inflammatory markers
* Contraindications to acupuncture: coagulation disorders or use of anticoagulants
* Pregnancy or breastfeeding
* Unable to comply with follow-up or contraindications to MRI (e.g., cardiac pacemaker, non-titanium aneurysm clips, metallic implants, claustrophobia)

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Principal investigator: Shabei Xu — Tongji Hospital
• Study coordinator: Wensheng Qu
• Email: Qws0309@163.com
• Phone: +86-18971622660

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fiber supplement plus counseling for constipation during pregnancy

  A daily fiber supplement (PHGG-based) with vitamin mix and nutrition counseling is being tested to see if it helps pregnant people with functional constipation.

  Recruiting Société des Produits Nestlé (SPN) · Osasco, São Paulo · NCT07588633

• Brain stimulation (tACS) for adults with stubborn constipation and somatic symptom disorder

  We will test whether four weeks of gentle brain stimulation (tACS) can improve bowel movements and symptoms in adults with refractory functional constipation and somatic symptom disorder.

  Recruiting at 2 sites Xijing Hospital of Digestive Diseases · Xi'an, Shaanxi and 1 other locations · NCT07323407

• Sea buckthorn supplement to improve bowel function in primary functional constipation

  This study will test whether a sea buckthorn (Hippophae rhamnoides) supplement at two different doses helps adults with primary functional constipation have more frequent, softer bowel movements and less bloating.

  Recruiting Istituto Farmochimico Fitoterapico: Epo Srl · Naples · NCT07082673

• Probiotics for treating constipation in adults

  This study is testing if a probiotic called ABKefir can help adults with constipation feel better after 8 weeks of treatment.

  Recruiting Chung Shan Medical University · Taichung, South · NCT06969872

• Probiotic treatment for constipation in pregnant women

  This study tests if a probiotic and a special liquid can help pregnant women with constipation feel better and improve their gut health.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality and 1 other locations · NCT06802042

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.