Constipation - FunctionalNCT06221722
Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation
An observational study of Constipation - Functional and Refractory Constipation, run by Xijing Hospital of Digestive Diseases at 3 sites in China.
Trial summary
The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are: Investigating the alterations in brain functional connectivity in patients with refractory constipation and… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation - Functional, Refractory Constipation, Fluoxetine
- What is being tested?
- BOLD-fMRI, Regular treatment of functional constipation and fluoxetine
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2023to 1 Sep 2026
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: tertiary hospitals received patients from northwest of China
Who may be able to join
- 18≤ age ≤ 45 years old
- Right-handed
- Patients diagnosed as functional constipation according to the Rome IV criteria
- Informed consent of patients
Who cannot join
- Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)
- Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)
- No history of chronic pain, no recent major trauma
- Drug abuse or tobacco dependence (half a pack or more per day)
- Combined hypothyroidism and Parkinson's disease
- Patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones
Show all 12Show fewer
- History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)
- Contraindications to functional magnetic resonance imaging (claustrophobia, metal implants)
- Pregnant or lactating women with constipation after delivery
- Patients with other benign and malignant tumors and autoimmune diseases
- Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.
- Heart disease, organ failure and other chronic diseases that require long-term medication or affect the quality of life
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710032
Qinxian Huang, 18402938222, zhaozhifeng@outlook.com
Qinxian Huang
- Recruiting
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Zhifeng Zhao, 13519171072, zhaozhifeng@outlook.com
Bin Yang
- Recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750002
Xuzhao Li, 13519171072, zhaozhifeng@outlook.com
Xuzhao Li
About this study
Official title: Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study
The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:
- Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients
- Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.
Read more
Participants will receive:
- Standard physiological and psychological assessments of constipation
- BOLD-fMRI tests
- Standard protocol and fluoxetine treatment
If there is a comparison group: Researchers will compare:
Refractory group/Fluoxetine sensitive group to see the specific brain alterations.
- Conditions
- Constipation - Functional, Refractory Constipation, Fluoxetine, fMRI, Brain Connectivity, Treatment Efficacy
- Being tested
- BOLD-fMRI, Regular treatment of functional constipation, fluoxetine
- Keywords
- fMRI, functional connectivity, refractory constipation
- Medical subject headings
- Constipation, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLD-fMRIDiagnostic test
Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging
Regular treatment of functional constipationDrug
at least 3 months of continuous regular treatment. This treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
fluoxetineDrug
Fluoxetine oral treatment for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Refractory constipation: fluoxetine sensitive | Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms. Receives: Diagnostic Test: BOLD-fMRI; Drug: Regular treatment of functional constipation; Drug: fluoxetine | |
| Refractory constipation: fluoxetine insensitive | Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms. Receives: Diagnostic Test: BOLD-fMRI; Drug: Regular treatment of functional constipation; Drug: fluoxetine | |
| Non-refractory constipation | Functional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. Receives: Diagnostic Test: BOLD-fMRI; Drug: Regular treatment of functional constipation | |
| Health Control | Volunteers without symptoms of constipation Receives: Diagnostic Test: BOLD-fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
BOLD-fMRI tests before and after fluoxetine treatment
Measured: 1-week pre and 4-week post of fluoxetine treatment
Secondary outcomes (5)
Changes in PAC-QOL self-assessment scores from baseline
The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire is a self-reported instrument designed to measure the quality of life in individuals with constipation. This tool comprises 28 items across four fundamental domains, including physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. In our study, the Chinese version (version 16) was utilized.
Measured: 1-week pre and 4-week post-fluoxetine treatment.
Changes in PHQ-15 self-assessment scores relative to baseline.
The Patient Health Questionnaire-15 (PHQ-15) is a self-reporting inventory that evaluates the severity of somatic symptoms in patients. Comprising 15 items, the questionnaire primarily focuses on experienced bodily symptoms and aids healthcare providers in identifying potential somatization disorders or severe somatic illnesses.
Measured: 1-week pre and 4-week post-fluoxetine treatment.
Changes in GAD-7 self-assessment scores from baseline.
The Generalized Anxiety Disorder-7 (GAD-7) is a brief measure assessing the frequency of anxiety symptoms over the past two weeks. With 7 items, the scale concentrates on the core symptoms of generalized anxiety disorder, serving as an instrument to ascertain the level of anxiety and to monitor the improvement of anxiety symptoms.
Measured: 1-week pre and 4-week post-fluoxetine treatment.
Changes in PHQ-9 self-assessment scores since baseline.
The Patient Health Questionnaire-9 (PHQ-9) is a tool used for screening, diagnosing, monitoring, and quantifying the severity of depression. The questionnaire consists of 9 items drawing from typical symptoms of depression, facilitating the evaluation of the presence and severity of depression by medical professionals.
Measured: 1-week pre and 4-week post-fluoxetine treatment.
Changes in KESS self-assessment scores from baseline.
The KESS questionnaire, Kovacs' Evaluation of Sphincter Symptoms, is utilized to assess defecatory dysfunction. It includes a series of items that inquire about constipation symptoms and defecatory habits, aiming to evaluate the severity and impact of a patient's defecatory disorders.
Measured: 1-week pre and 4-week post-fluoxetine treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Nov 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Zhao, PhD, Xijing Hospital of Digestive Diseases
- Investigators
- Qingchuan Zhao, Prof., Study chair, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221722
- Sponsor's protocol ID
- KY20232332-C-1
- Status last verified
- Jul 2025
- First submitted
- 26 Dec 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhaozhifeng@outlook.com.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT06221722
- Acronym / sponsor ID
- KY20232332-C-1
- Conditions
- Constipation - Functional, Refractory Constipation, Fluoxetine, fMRI, Brain Connectivity, Treatment Efficacy
- Keywords
- fMRI, functional connectivity, refractory constipation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Jan 2024 (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.
The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:
- Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients
- Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.
Participants will receive:
- Standard physiological and psychological assessments of constipation
- BOLD-fMRI tests
- Standard protocol and fluoxetine treatment
If there is a comparison group: Researchers will compare:
Refractory group/Fluoxetine sensitive group to see the specific brain alterations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Refractory constipation: fluoxetine sensitive | – | Diagnostic Test: BOLD-fMRI, Drug: Regular treatment of functional constipation, Drug: fluoxetineFunctional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms. |
| Refractory constipation: fluoxetine insensitive | – | Diagnostic Test: BOLD-fMRI, Drug: Regular treatment of functional constipation, Drug: fluoxetineFunctional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms. |
| Non-refractory constipation | – | Diagnostic Test: BOLD-fMRI, Drug: Regular treatment of functional constipationFunctional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. |
| Health Control | – | Diagnostic Test: BOLD-fMRIVolunteers without symptoms of constipation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- tertiary hospitals received patients from northwest of China
Key inclusion criteria (4 listed)
- 18≤ age ≤ 45 years old
- Right-handed
- Patients diagnosed as functional constipation according to the Rome IV criteria
- Informed consent of patients
Key exclusion criteria (12 listed)
- Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)
- Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)
- No history of chronic pain, no recent major trauma
- Drug abuse or tobacco dependence (half a pack or more per day)
- Combined hypothyroidism and Parkinson's disease
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 |
|---|---|---|
| BOLD-fMRIBlood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging | Diagnostic test | Health Control, Non-refractory constipation, Refractory constipation: fluoxetine insensitive, Refractory constipation: fluoxetine sensitive |
| Regular treatment of functional constipationat least 3 months of continuous regular treatment. This treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. | Drug | Non-refractory constipation, Refractory constipation: fluoxetine insensitive, Refractory constipation: fluoxetine sensitive |
| fluoxetineFluoxetine oral treatment for 4 weeks. | Drug | Refractory constipation: fluoxetine insensitive, Refractory constipation: fluoxetine sensitive |
Primary outcome
Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
Time frame: 1-week pre and 4-week post of fluoxetine treatment
BOLD-fMRI tests before and after fluoxetine treatment
5 secondary outcomes
Changes in PAC-QOL self-assessment scores from baseline
Time frame: 1-week pre and 4-week post-fluoxetine treatment.
Changes in PHQ-15 self-assessment scores relative to baseline.
Time frame: 1-week pre and 4-week post-fluoxetine treatment.
Changes in GAD-7 self-assessment scores from baseline.
Time frame: 1-week pre and 4-week post-fluoxetine treatment.
Changes in PHQ-9 self-assessment scores since baseline.
Time frame: 1-week pre and 4-week post-fluoxetine treatment.
Changes in KESS self-assessment scores from baseline.
Time frame: 1-week pre and 4-week post-fluoxetine 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 24 Jul 2025.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhaozhifeng@outlook.com.
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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.
Qingchuan Zhao, Prof. study chair
Xijing Hospital of Digestive Diseases
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation - Functional and Refractory Constipation, run by Xijing Hospital of Digestive Diseases at 3 sites in China.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Zhifeng Zhao (13519171072, zhaozhifeng@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment (time frame: 1-week pre and 4-week post of fluoxetine 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 24 Jul 2025.