Could a simple constipation treatment protect your kidneys?
NCT ID NCT06123195
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This small pilot study looked at whether treating constipation with a common laxative (lactulose) is practical for people with chronic kidney disease. Fourteen participants took lactulose daily for up to 6 weeks. The main goal was to see if people would stick with the treatment and complete the study. Researchers also checked for changes in kidney function and blood markers. The study was completed, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lactulose
- What this could lead to
- If successful, this could show that treating constipation is a safe and practical way to possibly improve kidney health in patients with chronic kidney disease.
- What could go wrong
- This is a very small pilot study with only 14 people, so results may not apply to everyone. It only tests feasibility, not whether constipation treatment actually improves kidney outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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14 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients \>18 years old. 2. Patients able and willing to provide written informed consent and HIPAA authorization. 3. 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. 4. Functional or opioid-induced constipation based on the Rome IV criteria. 5. 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. 6. 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. Exclusion Criteria: 1. History of drug abuse, anorexia nervosa, or bulimia. 2. History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever). 3. Liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included). 4. Galactosemia. 5. Allergies to lactulose. 6. History of gastrointestinal surgery except appendectomy. 7. Use of antibiotics or immunosuppressants within 30 days prior to the enrollment in the study. 8. Use of pre- or probiotics within 30 days prior to enrollment in the study. 9. Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding. 10. Patients currently participating in another interventional study. 11. 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. 12. Patients who the investigator determine have a medical status that would preclude the patient's participation. 13. Patients on hemodialysis or peritoneal dialysis. 14. Patients with a functional kidney transplant. 15. Patients with past lactulose use.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memphis VA Medical Center
Memphis, Tennessee, 38104, United States
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