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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:
Participants will receive:
If there is a comparison group: Researchers will compare:
Refractory group/Fluoxetine sensitive group to see the specific brain alterations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| Health Control | Volunteers without symptoms of constipation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOLD-fMRI | Diagnostic Test | Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment | BOLD-fMRI tests before and after fluoxetine treatment | 1-week pre and 4-week post of fluoxetine treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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tertiary hospitals received patients from northwest of China
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifeng Zhao | Contact | 13519171072 | zhaozhifeng@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingchuan Zhao, Prof. | Xijing Hospital of Digestive Diseases | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Ningxia Hui Autonomous Region | Recruiting | Yinchuan | Ningxia | 750002 | China |
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.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
For more information or to submit a request, please contact zhaozhifeng@outlook.com.
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Stool, Blood
|
| Regular treatment of functional constipation | Drug | 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. |
|
| fluoxetine | Drug | Fluoxetine oral treatment for 4 weeks. |
|
| 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. | 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. | 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. | 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. | 1-week pre and 4-week post-fluoxetine treatment. |
| Xi'an International Medical Center Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| ID | Term |
|---|---|
| D003248 | Constipation |
| D000071896 | Medically Unexplained Symptoms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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