BridgeMD
New treatment option for Functional Constipation (FC)
Official title Dose-Effect Response in Acupuncture for Functional Constipation
ClinicalTrials.gov ID: NCT07506122
What this study is testing
- What it's testing
- This is a single-center, randomized, parallel-group trial evaluating the dose-response relationship of two experimental interventions: manual acupuncture and electroacupuncture for functional constipation. A total of 72 participants with functional constipation (Rome IV criteria) will be randomly assigned in a 1:1 ratio to either the manual acupuncture group or the electroacupuncture group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)
You likely can't join if
- Constipation secondary to other causes (IBS, organic diseases, medications, endocrine disorders, metabolic disorders, neurological disorders, or...
- 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
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.