Refractory ConstipationNCT06750445
Fluoxetine for Refractory Constipation
A study testing Fluoxetine and Polyethylene Glycol 400 0.4% in people with Refractory Constipation, run by Zhifeng Zhao, PhD at 3 sites in China.
Trial summary
The goal of this clinical trial is to learn if fluoxetine works to treat refractory constipation . It will also learn about the safety of fluoxetine. The main questions it aims to answer are: Does fluoxetine increase the number of completely spontaneous bowel movements (CSBMs) per week? What medical problems do… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Constipation
- What is being tested?
- Fluoxetine and Polyethylene Glycol 400 0.4%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2020to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals aged 18 to 70 years;
- patients meeting the Rome IV diagnostic criteria for chronic constipation, defined by at least two symptoms: straining, lumpy or hard stools (Bristol Stool Scale types 1-2), incomplete evacuation, anorectal obstruction, need for manual maneuvers, or spontaneous bowel movements occurring less than three times per week. These symptoms must have persisted for a minimum of six months, with the diagnostic criteria being met for at least the past three months;
- refractory constipation, defined as the use of at least three medications (including osmotic agents, laxatives, prokinetics, biofeedback and probiotics, surgery) for more than three months, with unsatisfactory treatment outcomes;
- patients present indications for fluoxetine, such as comorbid depression;
- patients who voluntarily provided informed consent prior to enrollment.
Who cannot join
- women who are pregnant or lactating;
- presence of cardiovascular conditions, organ dysfunction, immune disorders, or infections;
- concurrent gastrointestinal organic conditions such as tuberculosis, polyps, Crohn's disease, tumors, etc.;
- prior abdominal surgeries;
- use of psychotropic medications; 6) diagnosis of hypothyroidism or Parkinson's disease.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, 710032
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710032
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750011
About this study
Official title: The Safety and Efficacy of Fluoxetine for Treatment of Refractory Constipation
The goal of this clinical trial is to learn if fluoxetine works to treat refractory constipation . It will also learn about the safety of fluoxetine. The main questions it aims to answer are:
Does fluoxetine increase the number of completely spontaneous bowel movements (CSBMs) per week? What medical problems do participants have when taking fluoxetine? Does fluoxetine improve psychological symptoms such as anxiety and depression in participants with refractory constipation? Researchers will compare fluoxetine to polyethylene glycol (PEG, a commonly used laxative) to see if fluoxetine works to treat refractory constipation.
Read more
Participants will:
Take fluoxetine (40 mg/day) or polyethylene glycol (once daily) for 6 months. Visit the clinic at baseline, and at 1 month, 3 months, and 6 months for checkups and tests.
Record their bowel movements and any changes in symptoms, including anxiety, depression, and side effects.
- Conditions
- Refractory Constipation
- Being tested
- Fluoxetine, Polyethylene Glycol 400 0.4%
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called polyethylene glycol
Patients in the fluoxetine group received oral fluoxetine starting at 40 mg/day for six months. Treatment was discontinued if serious adverse reactions developed or if no improvement was observed after dose escalation. Compliance and treatment progress were monitored via telephone follow-ups. For patients unable to have a bowel movement for three consecutive days or experiencing intolerable symptoms, polyethylene glycol (PEG, 10 g) was provided as rescue medication. Bowel movements within 24 hours of rescue medication use were excluded from the count of complete spontaneous bowel movements (CSBM).
Polyethylene Glycol 400 0.4%Drug
The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine Treatment Group | Experimental | Patients in the fluoxetine group received oral fluoxetine starting at 40 mg/day for six months. The dose could be increased to 60 mg/day if symptoms persisted or reduced if mild adverse effects (e.g., dizziness, nausea, tremors) occurred. Treatment was discontinued if serious adverse reactions developed or if no improvement was observed after dose escalation. Compliance and treatment progress were monitored via telephone follow-ups. For patients unable to have a bowel movement for three consecutive days or experiencing intolerable symptoms, polyethylene glycol (PEG, 10 g) was provided as rescue medication. Bowel movements within 24 hours of rescue medication use were excluded from the count of complete spontaneous bowel movements (CSBM). Receives: Drug: Fluoxetine |
| PEG Treatment Group | Active comparator | The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures. Receives: Drug: Polyethylene Glycol 400 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a CSBM of 3 or more per week
The primary endpoint of this study is the proportion of patients achieving a weekly frequency of three or more complete spontaneous bowel movements (CSBMs) after six months of treatment. A CSBM is defined as a bowel movement that occurs without the use of rescue medication (e.g., polyethylene glycol) within the preceding 24 hours. This endpoint aims to evaluate the efficacy of fluoxetine in improving bowel function in patients with refractory constipation as compared to the control group.
Measured: baseline, six months after treatment
Secondary outcomes (3)
Mean number of spontaneous bowel movements (SBMs) per week
Measured: baseline, 1 month, 3 months, 6 months
Mean number of complete spontaneous bowel movements (CSBMs) per week
Measured: baseline, 1 month, 3 months, 6 months
Stool consistency (Bristol Stool Form Scale, BSFS, scores of 3-5)
Measured: baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2020
- Primary completion30 Jun 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory ConstipationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhifeng Zhao, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhifeng Zhao, PhD, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750445
- Sponsor's protocol ID
- XJLL-KY20222069
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Fluoxetine for Treatment of Refractory Constipation
- ClinicalTrials.gov ID
- NCT06750445
- Acronym / sponsor ID
- XJLL-KY20222069
- Conditions
- Refractory Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Zhifeng Zhao, PhDUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Dec 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 clinical trial is to learn if fluoxetine works to treat refractory constipation . It will also learn about the safety of fluoxetine. The main questions it aims to answer are:
Does fluoxetine increase the number of completely spontaneous bowel movements (CSBMs) per week? What medical problems do participants have when taking fluoxetine? Does fluoxetine improve psychological symptoms such as anxiety and depression in participants with refractory constipation? Researchers will compare fluoxetine to polyethylene glycol (PEG, a commonly used laxative) to see if fluoxetine works to treat refractory constipation.
Participants will:
Take fluoxetine (40 mg/day) or polyethylene glycol (once daily) for 6 months. Visit the clinic at baseline, and at 1 month, 3 months, and 6 months for checkups and tests.
Record their bowel movements and any changes in symptoms, including anxiety, depression, and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine Treatment Group | Experimental | Drug: FluoxetinePatients in the fluoxetine group received oral fluoxetine starting at 40 mg/day for six months. The dose could be increased to 60 mg/day if symptoms persisted or reduced if mild adverse effects (e.g., dizziness, nausea, tremors) occurred. Treatment was discontinued if serious adverse reactions developed or if no improvement was observed after dose escalation. Compliance and treatment progress were monitored via telephone follow-ups. For patients unable to have a bowel movement for three consecutive days or experiencing intolerable symptoms, polyethylene glycol (PEG, 10 g) was provided as rescue medication. Bowel movements within 24 hours of rescue medication use were excluded from the count of complete spontaneous bowel movements (CSBM). |
| PEG Treatment Group | Active comparator | Drug: Polyethylene Glycol 400 0.4%The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- individuals aged 18 to 70 years;
- patients meeting the Rome IV diagnostic criteria for chronic constipation, defined by at least two symptoms: straining, lumpy or hard stools (Bristol Stool Scale types 1-2), incomplete evacuation, anorectal obstruction, need for manual maneuvers, or spontaneous bowel movements occurring less than three times per week. These symptoms must have persisted for a minimum of six months, with the diagnostic criteria being met for at least the past three months;
- refractory constipation, defined as the use of at least three medications (including osmotic agents, laxatives, prokinetics, biofeedback and probiotics, surgery) for more than three months, with unsatisfactory treatment outcomes;
- patients present indications for fluoxetine, such as comorbid depression;
- patients who voluntarily provided informed consent prior to enrollment.
Key exclusion criteria (5 listed)
- women who are pregnant or lactating;
- presence of cardiovascular conditions, organ dysfunction, immune disorders, or infections;
- concurrent gastrointestinal organic conditions such as tuberculosis, polyps, Crohn's disease, tumors, etc.;
- prior abdominal surgeries;
- use of psychotropic medications; 6) diagnosis of hypothyroidism or 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 |
|---|---|---|
| FluoxetineAlso: polyethylene glycolPatients in the fluoxetine group received oral fluoxetine starting at 40 mg/day for six months. Treatment was discontinued if serious adverse reactions developed or if no improvement was observed after dose escalation. Compliance and treatment progress were monitored via telephone follow-ups. For patients unable to have a bowel movement for three consecutive days or experiencing intolerable symptoms, polyethylene glycol (PEG, 10 g) was provided as rescue medication. Bowel movements within 24 hours of rescue medication use were excluded from the count of complete spontaneous bowel movements (CSBM). | Drug | Fluoxetine Treatment Group |
| Polyethylene Glycol 400 0.4%The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures. | Drug | PEG Treatment Group |
Primary outcome
Proportion of patients with a CSBM of 3 or more per week
Time frame: baseline, six months after treatment
The primary endpoint of this study is the proportion of patients achieving a weekly frequency of three or more complete spontaneous bowel movements (CSBMs) after six months of treatment. A CSBM is defined as a bowel movement that occurs without the use of rescue medication (e.g., polyethylene glycol) within the preceding 24 hours. This endpoint aims to evaluate the efficacy of fluoxetine in improving bowel function in patients with refractory constipation as compared to the control group.
3 secondary outcomes
Mean number of spontaneous bowel movements (SBMs) per week
Time frame: baseline, 1 month, 3 months, 6 months
Mean number of complete spontaneous bowel movements (CSBMs) per week
Time frame: baseline, 1 month, 3 months, 6 months
Stool consistency (Bristol Stool Form Scale, BSFS, scores of 3-5)
Time frame: baseline, 1 month, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine and Polyethylene Glycol 400 0.4% in people with Refractory Constipation, run by Zhifeng Zhao, PhD 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a CSBM of 3 or more per week (time frame: baseline, six months 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 18 Jun 2025.