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NCT06891105: ProSyn-HD
Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients
NA trial testing Lactogemikan (Probiotic Supplement) in Hemodialysis in 60 participants. Not yet recruiting.
15 October 2025
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 15 April 2025 |
| Primary completion | 15 October 2025 |
| Estimated completion | 1 November 2025 |
Drugs / interventions tested
- Lactogemikan (Probiotic Supplement)
- Lactogemikan + Prebiotic Fiber (Synbiotic Supplement)
Conditions studied
- Hemodialysis — all drugs for Hemodialysis →
- Probiotics — all drugs for Probiotics →
- Synbiotics — all drugs for Synbiotics →
- Nutritional Status — all drugs for Nutritional Status →
Sponsor
Mansoura University
Who can join
18 and older, any sex, with Hemodialysis or Probiotics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to investigate the impact of probiotics and synbiotics on the nutritional status of patients with end-stage kidney disease (ESRD) who are undergoing hemodialysis. ESRD patients often face challenges such as poor nutritional status, increased risk of infections, and imbalances in gut microbiota. These challenges are made worse by the frequent use of medications, dietary restrictions, and the hemodialysis process itself, which can disturb the gut's natural bacteria balance. Probiotics are live microorganisms that provide health benefits when taken in adequate amounts, while synbiotics are a combination of probiotics and prebiotics (substances that promote the growth of beneficial bacteria). The goal of this study is to explore whether supplementing ESRD patients with probiotics or synbiotics can improve their nutritional health, including aspects like body mass index (BMI), skin fold thickness, and protein metabolism. The study will involve 60 patients from a hemodialysis center in Mansoura, Egypt. Patients will be randomly assigned to one of three groups: one group will receive probiotics, another will receive synbiotics, and the third group will act as a control (no treatment). The study will evaluate changes in nutritional markers and other health parameters before and after six months of supplementation. This study hopes to provide insights into new, cost-effective interventions for improving the health of patients undergoing long-term dialysis treatment by addressing the question of whether these supplements can improve the nutritional status of hemodialysis patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of probiotic and synbiotic administration on the nutritional status of hemodialysis patients: a randomized-controlled trial.
Saad WM, Moheb Y, Wafa E, Elhadedy MA, et al · · 2026 · PMID 41872650 · DOI 10.1007/s11255-026-05070-y
Verify or expand the search:
- PubMed search for NCT06891105
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06891105 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 24 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06891105.
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