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NCT Number: NCT07394920

The Role of Sodium Bicarbonate Enema in Improving Constipation and Reducing Uremic Toxins in Chronic Kidney Disease Patients.

Chronic kidney disease (CKD) is a progressive condition characterized by a gradual loss of kidney function, often resulting in the accumulation of metabolic waste products. One of the emerging areas of interest in CKD management is the gut-kidney axis, which highlights the interplay between gut microbiota and renal health. CKD patients frequently exhibit gut dysbiosis and increased production of gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate, which can further exacerbate kidney damage and systemic inflammation.

CKD causes acidosis because damaged kidneys can't effectively excrete acids from the body or produce enough bicarbonate to neutralize them. This imbalance leads to a buildup of acids in the blood, resulting in metabolic acidosis, where acid levels in the blood become greater than normal.

Recent evidence suggests a close association between constipation and clinical outcomes such as cardiovascular disease, CKD progression and mortality(1-4). In particular, numerous observational studies have reported a higher prevalence of constipation in patients with CKD. Although the global prevalence of constipation in the general population has been estimated at approximately 14%, the prevalence in patients with CKD is reported to be much higher(5). A recent meta analysis reported a constipation prevalence of 38.8% in patients with advanced non-dialysis CKD(6). Patients with end-stage renal disease (ESRD) have been shown to have a substantially higher constipation prevalence, with some studies reporting over 50%(7).

This study focuses on using the GIT as an additional excretory pathway of the uremic toxins via using sodium bicarbonate enema in patients with CKD.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Adults aged 18-60 years
  • Diagnosed with CKD stage 3-4
  • Stable renal function for 3 months
  • Able to give informed consent

Exclusion criteria

  • - Active GI disease (IBD, colon cancer, severe hemorrhoids, anal fissure)
  • Recent abdominal or colorectal surgery
  • Severe cardiovascular conditions
  • Pregnancy or breastfeeding
  • Electrolyte imbalance

Treatment and study plan

sodium bicarbonate enema

Procedure

patients with CKD will recived sodium bicarbonate enema

Primary outcomes

  1. uremic toxins level

    Time frame: 3 months

    uremic toxins level after sodium bicarbonate enema

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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