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Behavioural Intervention

Constipation treatment for Constipation

Q: Are there any ongoing efforts to enroll patients in this current medical study?

<p>Per information from clinicaltrials.gov, this investigation is currently open for participant enrollment. It was initially listed on 1st January 2024 and most recently revised on 12th February 2024.</p>

Q: What is the current participation count in this clinical trial?

<p>Affirmative. Information retrieved from clinicaltrials.gov confirms the active patient recruitment for this study. The trial was first listed on January 1, 2024, and recently revised on February 12, 2024. Recruitment aims to enroll a total of 40 participants at a single site.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have constipation as defined by specific medical criteria.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Changes in constipation symptoms

Changes in microbial parameters

Changes in plasma C-reactive protein

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Constipation treatmentExperimental Treatment1 Intervention

A 4-week intervention of constipation treatment with lactulose

Group II: ControlActive Control1 Intervention

No constipation treatment except bisacodyl rescue therapy

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of TennesseeLead Sponsor

189 Previous Clinical Trials

141,989 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,552 Total Patients Enrolled

9 Trials studying Constipation

17,145 Patients Enrolled for Constipation

University of FloridaOTHER

1,341 Previous Clinical Trials

715,606 Total Patients Enrolled

1 Trials studying Constipation

35 Patients Enrolled for Constipation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll patients in this current medical study?

"Per information from clinicaltrials.gov, this investigation is currently open for participant enrollment. It was initially listed on 1st January 2024 and most recently revised on 12th February 2024."

Answered by AI

What is the current participation count in this clinical trial?

"Affirmative. Information retrieved from clinicaltrials.gov confirms the active patient recruitment for this study. The trial was first listed on January 1, 2024, and recently revised on February 12, 2024. Recruitment aims to enroll a total of 40 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06123195.

All > Chronic Kidney Disease