Chronic Kidney DiseaseNCT06123195
Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial
A study testing Constipation treatment in people with Chronic Kidney Disease and Constipation, run by University of Tennessee at 1 site in United States.
Trial summary
Constipation is one of the most prevalent gastrointestinal disorders in patients with chronic kidney disease (CKD) and has been associated with their adverse kidney and cardiovascular outcomes; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Constipation
- What is being tested?
- Constipation treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 17 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients >18 years old.
- Patients able and willing to provide written informed consent and HIPAA authorization.
- CKD stages G3-G5 without kidney replacement therapy with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 creatinine equation.
- Functional or opioid-induced constipation based on the Rome IV criteria.
- Patients must refrain from taking any laxatives for at least one week prior to screening, although rescue with one bisacodyl 5 mg tablet will be allowed when a patient does not have a bowel movement for ≥3 consecutive days or when symptoms become intolerable.
- A negative pregnancy test in female patients prior to enrolment, unless the patient is two years postmenopausal or has had a documented tubal ligation or hysterectomy.
Who cannot join
- History of drug abuse, anorexia nervosa, or bulimia.
- History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever).
- Liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included).
- Galactosemia.
- Allergies to lactulose.
- History of gastrointestinal surgery except appendectomy.
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- Use of antibiotics or immunosuppressants within 30 days prior to the enrollment in the study.
- Use of pre- or probiotics within 30 days prior to enrollment in the study.
- Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding.
- Patients currently participating in another interventional study.
- Major surgery within one month prior to enrollment in the study or planned surgery while the patient is in the study, other than dialysis vascular access surgery.
- Patients who the investigator determine have a medical status that would preclude the patient's participation.
- Patients on hemodialysis or peritoneal dialysis.
- Patients with a functional kidney transplant.
- Patients with past lactulose use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Biochemical, and Microbiological Effects of Constipation Treatment in Patients With Chronic Kidney Disease: A Pilot Feasibility Trial
Constipation is one of the most prevalent gastrointestinal disorders in patients with chronic kidney disease (CKD) and has been associated with their adverse kidney and cardiovascular outcomes; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical and microbiological parameters in patients with CKD. The investigators aim to test the feasibility of delivering an intervention with constipation treatment and determine its effects on changes in clinical, biochemical, and microbiological parameters in patients with CKD and constipation.
- Conditions
- Chronic Kidney Disease, Constipation
- Being tested
- Constipation treatment
- Keywords
- Chronic Kidney Disease, Constipation, Microbiota
- Medical subject headings
- Renal Insufficiency, Chronic, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constipation treatmentOther
Lactulose 15 mL (10 g) will be taken orally once daily (in the evening), which can be titrated at 1-week intervals in 15 mL (10 g) increments or decrements up to 60 mL (40 g) as a total daily dose.
| Study group | Role | What they receive |
|---|---|---|
| Constipation treatment | Experimental | A 4-week intervention of constipation treatment with lactulose Receives: Other: Constipation treatment |
| Control | No intervention | No constipation treatment except bisacodyl rescue therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol
The feasibility of delivering the applied interventions and performing the proposed examinations will be determined based on the following feasibility outcomes, assessed as 1) ≥90% of participants randomized in the intervention group and under observation will adhere to the proposed intervention, 2) ≥80% patients under observation will adhere to the study-specific timed collection of stool, urine, and blood samples, and 3) ≥85% patients will complete the study (<15% patients will be dropped out).
Measured: From enrollment to the end of follow-up at 6 weeks
Secondary outcomes (10)
Changes in serum creatinine
Changes in serum creatinine from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in serum phosphorus
Changes in serum phosphorus from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in serum p-cresyl sulfate and indoxyl sulfate
Changes in serum p-cresyl sulfate and indoxyl sulfate from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in plasma potassium
Changes in plasma potassium from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in plasma C-reactive protein
Changes in plasma C-reactive protein from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in plasma lipopolysaccharide
Changes in plasma lipopolysaccharide from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in urine albumin-creatinine ratio (UACR) and protein-creatinine ratio (UPCR)
Changes in urine albumin-creatinine ratio (UACR) and protein-creatinine ratio (UPCR) from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in microbial parameters
Changes in gut and circulating microbiota from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in stool consistency
Changes in stool consistency assessed by Bristol Stool Form Scale (BSFS) from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Changes in constipation symptoms
Changes in constipation symptoms assessed by Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 2, 4, and 6 weeks.
Measured: From enrollment to the end of follow-up at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Feb 2024
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, open-label, randomized, controlled, parallel-group, pilot feasibility trial
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123195
- Sponsor's protocol ID
- 23-09272-XP
- Other IDs
- R01DK135942
- Status last verified
- Dec 2025
- First submitted
- 30 Oct 2023
- Last updated
- 4 Dec 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biochemical, and Microbiological Effects of Constipation Treatment in Patients With Chronic Kidney Disease: A Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT06123195
- Acronym / sponsor ID
- 23-09272-XP
- Conditions
- Chronic Kidney Disease, Constipation
- Keywords
- Chronic Kidney Disease, Constipation, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Florida
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 8 Nov 2023 (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.
Constipation is one of the most prevalent gastrointestinal disorders in patients with chronic kidney disease (CKD) and has been associated with their adverse kidney and cardiovascular outcomes; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical and microbiological parameters in patients with CKD. The investigators aim to test the feasibility of delivering an intervention with constipation treatment and determine its effects on changes in clinical, biochemical, and microbiological parameters in patients with CKD and constipation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, open-label, randomized, controlled, parallel-group, pilot feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Constipation treatment | Experimental | Other: Constipation treatmentA 4-week intervention of constipation treatment with lactulose |
| Control | No intervention | –No constipation treatment except bisacodyl rescue therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients >18 years old.
- Patients able and willing to provide written informed consent and HIPAA authorization.
- CKD stages G3-G5 without kidney replacement therapy with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 creatinine equation.
- Functional or opioid-induced constipation based on the Rome IV criteria.
- Patients must refrain from taking any laxatives for at least one week prior to screening, although rescue with one bisacodyl 5 mg tablet will be allowed when a patient does not have a bowel movement for ≥3 consecutive days or when symptoms become intolerable.
Key exclusion criteria (15 listed)
- History of drug abuse, anorexia nervosa, or bulimia.
- History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever).
- Liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included).
- Galactosemia.
- Allergies to lactulose.
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 |
|---|---|---|
| Constipation treatmentLactulose 15 mL (10 g) will be taken orally once daily (in the evening), which can be titrated at 1-week intervals in 15 mL (10 g) increments or decrements up to 60 mL (40 g) as a total daily dose. | Other | Constipation treatment |
Primary outcome
The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol
Time frame: From enrollment to the end of follow-up at 6 weeks
The feasibility of delivering the applied interventions and performing the proposed examinations will be determined based on the following feasibility outcomes, assessed as 1) ≥90% of participants randomized in the intervention group and under observation will adhere to the proposed intervention, 2) ≥80% patients under observation will adhere to the study-specific timed collection of stool, urine, and blood samples, and 3) ≥85% patients will complete the study (<15% patients will be dropped out).
10 secondary outcomes
Changes in serum creatinine
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in serum phosphorus
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in serum p-cresyl sulfate and indoxyl sulfate
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in plasma potassium
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in plasma C-reactive protein
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in plasma lipopolysaccharide
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in urine albumin-creatinine ratio (UACR) and protein-creatinine ratio (UPCR)
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in microbial parameters
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in stool consistency
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in constipation symptoms
Time frame: From enrollment to the end of follow-up at 6 weeks
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 4 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constipation treatment in people with Chronic Kidney Disease and Constipation, run by University of Tennessee at 1 site in United States.
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 6 inclusion and 15 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol (time frame: From enrollment to the end of follow-up at 6 weeks). 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 4 Dec 2025.