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Behavioural Intervention

Constipation Treatment for Chronic Kidney Disease

N/A

Recruiting

Research Sponsored by University of Tennessee

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Functional or opioid-induced constipation based on the Rome IV criteria

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

Must not have

Galactosemia

History of gastrointestinal surgery except appendectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end of follow-up at 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of constipation treatment on patients with chronic kidney disease. Researchers want to see if treating constipation can improve kidney and heart health outcomes and if it has any impact on

Who is the study for?

This trial is for adults over 18 with chronic kidney disease stages G3-G5 who are not on dialysis, have an eGFR under 60 mL/min/1.73m2, and suffer from functional or opioid-induced constipation. Participants must stop taking laxatives a week before the study but can use a rescue tablet if needed. Women must test negative for pregnancy unless postmenopausal or surgically sterile.

What is being tested?

The trial is exploring how treating constipation affects people with chronic kidney disease (CKD). It will look at whether this treatment can improve clinical outcomes and influence biochemical and microbiological parameters in patients with CKD who also experience constipation.

What are the potential side effects?

While specific side effects are not listed, typical reactions to constipation treatments may include abdominal pain, bloating, diarrhea, nausea, and sometimes electrolyte imbalances which could be significant in patients with CKD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have constipation as defined by specific medical criteria.

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My kidney function is reduced (eGFR <60) and I am not on dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have galactosemia.

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I have had surgery on my digestive system, but not for appendicitis.

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I haven't had major surgery in the last month and don't plan any during the study, except for dialysis access surgery.

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I have a history of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile infection.

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I am currently on dialysis.

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I have a working kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end of follow-up at 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of follow-up at 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of follow-up at 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol

Secondary study objectives

Changes in constipation symptoms

Changes in microbial parameters

Changes in plasma C-reactive protein

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