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

NCT07394920 | Not Yet Recruiting

• 1 other identifier: sodium bicarbonate enema CKD
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• uremic toxins level

  uremic toxins level after sodium bicarbonate enema

  3 months

Study Arms (1)

study group

ACTIVE COMPARATOR

patients with CKD will recived sodium bicarbonate enema

Procedure: sodium bicarbonate enema

Interventions

sodium bicarbonate enema PROCEDURE

patients with CKD will recived sodium bicarbonate enema

study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01