RECRUITING

Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial

Conditions

Chronic Kidney Disease Constipation Microbiota

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical, Biochemical, and Microbiological Effects of Constipation Treatment in Patients With Chronic Kidney Disease: A Pilot Feasibility Trial

Quick Facts

Study Start:2024-02-01

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06123195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Keiichi Sumida, MD, MPH, PhD

CONTACT

901-448-2339

ksumida@uthsc.edu

Csaba P. Kovesdy, MD

CONTACT

901-448-2985

ckovesdy@uthsc.edu

Study Locations (Sites)

Memphis VA Medical Center

Memphis, Tennessee, 38104

United States

Collaborators and Investigators

Sponsor: University of Tennessee

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01

Study Completion Date2025-07

Study Record Updates

Study Start Date2024-02-01

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Chronic Kidney Disease
Constipation
Microbiota

Additional Relevant MeSH Terms

Chronic Kidney Disease
Constipation