A comparative clinical trial of two different probiotic combinations on the renal outcome in CKD patients
- Conditions
- Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
- Registration Number
- CTRI/2019/10/021546
- Lead Sponsor
- Sanzyme P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
All the following criteria must be met at screening prior to randomization and at enrolment:
1. Either gender >18 to <75 years (both inclusive)
2. Patients diagnosed with CKD stages 3 or 4 and have been stable for at least 6 months
a. Stage 3 CKD: Moderate reduction in GFR (30-59 mL/min/1.73 m2)
b. Stage 4 CKD: Severe reduction in GFR (15-29 mL/min/1.73 m2)
3. Serum Creatinine levels greater than 2.5 mg/dL at the time of screening.
4. Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study
5. Willing to sign the written informed consent prior to inclusion in the study at the time of screening.
Any of the following criteria will preclude the participant from being enrolled in the study:
1. Pregnant or Nursing women,
2. Antibiotic treatment at the time of screening or within 14 days before screening
3. Positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or Hepatitis C.
4. Active dependency on controlled substances and alcohol,
5. Anticoagulant therapy regimen,
6. Not willing to sign the Informed Consent Form
7. Administration of an investigational drug either currently or within 30 days of screening.
8. Active addictive drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment.
9. Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
10. Significant pre-existing cardiac or pulmonary or hepatic or neurological co-morbidities
11. Patients with social conditions or medical debilitating disease/disorder, which, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent or affect overall prognosis of the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy and safety of a probiotic combination Lobun Forte® as measured through improvement in quality of life or reduction in levels of known uremic toxins as compared to Renadyl® in stage 3-4 CKD patients. <br/ ><br>- Quality of Life (QoL) SF 8 Questionnaire <br/ ><br>- Subjective Global Assessment (SGA) <br/ ><br>- Blood Urea Nitrogen (BUN) <br/ ><br>- Serum Creatinine <br/ ><br>- Serum Uric Acid <br/ ><br>- Uremic toxins plasma levels (indoxyl sulfate, p-cresyl sulfate, and indole-3-acetic acid)Timepoint: 5 Visits - study duration of 180 days. Visit every 45 days.
- Secondary Outcome Measures
Name Time Method - To investigate the effect of a probiotic combination on several biomarkers of inflammation and oxidative stress. <br/ ><br>hs CRP, IL-6, TNF-α (Inflammatory Biomarkers) <br/ ><br>NO, MDA, GSH (Biomarkers of Oxidative stress) - To examine the effects of a probiotic combination on Estimated Glomerular Filtration (eGFR) and Patient compliance and adherence to the treatment schedule.Timepoint: 5 Visits - study duration of 180 days. Visit every 45 days.