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Impact of pre- and probiotic Supplementation on CKD Patients on Hemodialysis

Impact of pre and probiotic supplemnentation on gut microbiota, inflammation and oxidative stress in CKD patients on hemodialysis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097075
Enrollment
90
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N185- Chronic kidney disease, stage 5

Interventions

Intervention1: Presential Forte Prebiotic & Probiotic Capsule for Gut Health: Dosage: 1 capsule/day containing Bifidobacterium longum (15Billion Spores) + Fructo Oligosaccharide (100mg) + Lactobacillu

Sponsors

Sangeeth Kumar Indu Kumar
Lead Sponsor
Believers Church Medical College Hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 to 70 years with diagnosed chronic kidney disease (CKD). Patients undergoing maintenance hemodialysis for at least 12 weeks. Patients who have not used antibiotics or probiotics in the past 4 weeks. Individuals capable of giving informed consent to participate. Healthy age and sex matched individuals without chronic illness will also be enrolled as controls.

Exclusion criteria

Exclusion criteria: PHASE: 1 Exclusion Criteria Patients with Crohn’s disease, CVD, uncontrolled hypertension, ulcerative colitis, HIV/AIDS/liver disease, previous renal transplant, irritable bowel syndrome Pregnant or nursing women were also excluded Recent infections or hospitalisation Liver disease, malignancy, or autoimmune conditions Phase 2 Exclusion Criteria Allergy related to pre and probiotics

Design outcomes

Primary

MeasureTime frame
Proof of disease specific microbial signatures or biomarkers associated with CKD patients on hemodialysis compared to the healthy controlsTimepoint: At baseline sample will be analyzed

Secondary

MeasureTime frame
Document the gut inflammation and systemic markers in patients with CKD before and after hemodialysisTimepoint: Pre and post intervention will be analyzed (0, 4 and 8 weeks);Document the impact of pre and probiotics supplementation and gut microbiome modulation in patients with CKD on hemodialysis. Timepoint: Pre and post intervention will be analyzed (0, 4 and 8 weeks)

Countries

India

Contacts

Public ContactGiriprasad Venugopal

Believers Church Medical College Hospital

giriprsd36@gmail.com9677048798

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026