Functional Constipation (FC)NCT07010367
Baliao Acupoint Stimulation toTreat Functional Constipation
A study testing Acupuncture in people with Functional Constipation (FC), run by Affiliated Hospital of Nanjing University of Chinese Medicine.
Trial summary
This study is a randomized controlled trial that explores how a specific acupuncture treatment might help people with functional constipation. The investigators are testing the idea that a treatment called "acupuncture at the Baliao acupoints" could work by changing the way certain parts of the brain connect and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18 years or older.
- Diagnosed with functional constipation according to the Rome IV criteria.
- The participant has not received any treatment for functional constipation in the past two weeks (except for emergency interventions).
- Right-handed.
- Signed a written informed consent form to participate in this study.
Who cannot join
- Presence of organic constipation, drug-induced constipation, or systemic constipation.
- Presence of metallic foreign bodies in the body, pacemakers, or other contraindications for MRI examination.
- Communication disorders or unwillingness to cooperate with treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects and Mechanism of Baliao Acupoint Stimulation (BL31~BL34) for Functional Constipation
This study is a randomized controlled trial that explores how a specific acupuncture treatment might help people with functional constipation. The investigators are testing the idea that a treatment called "acupuncture at the Baliao acupoints" could work by changing the way certain parts of the brain connect and function. These brain changes might help improve gut function and relieve constipation symptoms.
The investigators will work with people who have functional constipation. Some participants will receive the real Baliao acupoint thread embedding, while others will get a sham acupuncture as a comparison. Using special brain imaging techniques, the investigators will look at how the brain's connections and structures change. The investigators will also track how often participants have bowel movements, the consistency of their stools, and their overall symptoms and quality of life. By comparing these results, the investigators hope to understand how the Baliao acupoint treatment works and why it might be effective for constipation.
- Conditions
- Functional Constipation (FC)
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- functional constipation, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Patients will be instructed to lie in the supine position. After strict disinfection of the acupoints area, acupuncture needles will be inserted into the Baliao points (inserted at the surface projections of the first, second, and third pairs of sacral foramina, with a depth of 3-4 cm). The treatment will be administered five times per week, with each session lasting 30 minutes, for a total of two weeks.
Sham acupunctureProcedure or surgery
Patients will be instructed to lie in the supine position. After strict disinfection of the sham acupoints area, acupuncture needles will be inserted lateral to the surface projections of the first, second, and third pairs of sacral foramina, with a depth of 1 cm.The treatment will be administered five times per week, with each session lasting 30 minutes, for a total of two weeks.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | Patients will receive acupuncture at Baliao acupuncts. Receives: Procedure: Acupuncture |
| sham group | Sham comparator | Patients will receive sham acupuncture treatment. Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous bowel movements
Spontaneous bowel movements (SBMs) refers to the frequency of bowel movements that occur without the use of any medications or other aids within the past 24 hours. These data are collected from the constipation diaries filled out daily by patients with functional constipation (FC) to determine the weekly count of SBMs. The data collection time points include before treatment and at 2, 4, 6, and 8 weeks after treatment.
Measured: SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
Secondary outcomes (2)
PAC-SYM
Patient Assessment of Constipation symptom(PAC-SYM) is a tool used to evaluate the symptoms and severity of constipation in patients. The scale consists of three sections: stool symptoms, rectal symptoms, and abdominal symptoms, with a total of 12 items. The score ranges from 0 to 48, with higher scores indicating more severe constipation symptoms.
Measured: PAC-SYM will be assessed at 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment
PAC-QOL
Patient Assessment of Constipation quality of life is a tool used to assess the impact of constipation on patients' quality of life. The scale, known as PAC-QOL, consists of four dimensions: Physical Discomfort (4 items), Psychosocial Discomfort (8 items), Worries and Discomfort (11 items), and Treatment Satisfaction (5 items), with a total of 28 items. The score ranges from 0 to 112, with higher scores indicating a greater negative impact of constipation on quality of life.
Measured: PAC-QOL will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nanjing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010367
- Sponsor's protocol ID
- 2024-056-SO
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data contains highly sensitive and personal information about study participants. Sharing IPD could potentially compromise participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanism of Baliao Acupoint Stimulation (BL31~BL34) for Functional Constipation
- ClinicalTrials.gov ID
- NCT07010367
- Acronym / sponsor ID
- 2024-056-SO
- Conditions
- Functional Constipation (FC)
- Keywords
- functional constipation, fMRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nanjing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial that explores how a specific acupuncture treatment might help people with functional constipation. The investigators are testing the idea that a treatment called "acupuncture at the Baliao acupoints" could work by changing the way certain parts of the brain connect and function. These brain changes might help improve gut function and relieve constipation symptoms.
The investigators will work with people who have functional constipation. Some participants will receive the real Baliao acupoint thread embedding, while others will get a sham acupuncture as a comparison. Using special brain imaging techniques, the investigators will look at how the brain's connections and structures change. The investigators will also track how often participants have bowel movements, the consistency of their stools, and their overall symptoms and quality of life. By comparing these results, the investigators hope to understand how the Baliao acupoint treatment works and why it might be effective for constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Procedure: AcupuncturePatients will receive acupuncture at Baliao acupuncts. |
| sham group | Sham comparator | Procedure: Sham acupuncturePatients will receive sham acupuncture treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age:18 years or older.
- Diagnosed with functional constipation according to the Rome IV criteria.
- The participant has not received any treatment for functional constipation in the past two weeks (except for emergency interventions).
- Right-handed.
- Signed a written informed consent form to participate in this study.
Key exclusion criteria (3 listed)
- Presence of organic constipation, drug-induced constipation, or systemic constipation.
- Presence of metallic foreign bodies in the body, pacemakers, or other contraindications for MRI examination.
- Communication disorders or unwillingness to cooperate with treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupuncturePatients will be instructed to lie in the supine position. After strict disinfection of the acupoints area, acupuncture needles will be inserted into the Baliao points (inserted at the surface projections of the first, second, and third pairs of sacral foramina, with a depth of 3-4 cm). The treatment will be administered five times per week, with each session lasting 30 minutes, for a total of two weeks. | Procedure or surgery | acupuncture group |
| Sham acupuncturePatients will be instructed to lie in the supine position. After strict disinfection of the sham acupoints area, acupuncture needles will be inserted lateral to the surface projections of the first, second, and third pairs of sacral foramina, with a depth of 1 cm.The treatment will be administered five times per week, with each session lasting 30 minutes, for a total of two weeks. | Procedure or surgery | sham group |
Primary outcome
Spontaneous bowel movements
Time frame: SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
Spontaneous bowel movements (SBMs) refers to the frequency of bowel movements that occur without the use of any medications or other aids within the past 24 hours. These data are collected from the constipation diaries filled out daily by patients with functional constipation (FC) to determine the weekly count of SBMs. The data collection time points include before treatment and at 2, 4, 6, and 8 weeks after treatment.
2 secondary outcomes
PAC-SYM
Time frame: PAC-SYM will be assessed at 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment
PAC-QOL
Time frame: PAC-QOL will be accessed 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No. Individual Participant Data contains highly sensitive and personal information about study participants. Sharing IPD could potentially compromise participant privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Functional Constipation (FC), run by Affiliated Hospital of Nanjing University of Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Wei (+86 15951953206, wisteria998@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous bowel movements (time frame: SBMs will be recorded 1 week before treatment and at 2, 4, 6, and 8 weeks after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.