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NCT04527640
Effects of Synbiotics Supplementation on the Uremic Toxin Indoxyl Sulfate Level and Constipation in End-stage Renal Disease Patients Undergoing Hemodialysis
NA trial testing Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg in Constipation in 60 participants. Status unknown.
31 January 2021
Quick facts
| Lead sponsor | Indonesia University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 15 September 2020 |
| Primary completion | 31 January 2021 |
| Estimated completion | 28 February 2021 |
Drugs / interventions tested
- Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg
- Placebo
Conditions studied
- Constipation — all drugs for Constipation →
- End Stage Renal Disease on Dialysis — all drugs for End Stage Renal Disease on Dialysis →
Sponsor
Indonesia University
Who can join
18 and older, any sex, with Constipation or End Stage Renal Disease on Dialysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a double-blind, placebo-controlled, randomized clinical trial conducted to evaluate the effects of synbiotics supplementation on the level of the uremic toxin indoxyl sulfate, symptoms of constipation, and constipation-related quality of life in end-stage renal disease patients undergoing hemodialysis.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Uremic Toxins in the Progression of Chronic Kidney Disease and Cardiovascular Disease: Mechanisms and Therapeutic Targets.
Lim YJ, Sidor NA, Tonial NC, Che A, et al · · 2021 · cited 227× · PMID 33668632 · DOI 10.3390/toxins13020142 -
Synbiotics, prebiotics and probiotics for people with chronic kidney disease.
Cooper TE, Khalid R, Chan S, Craig JC, et al · · 2023 · cited 35× · PMID 37870148 · DOI 10.1002/14651858.cd013631.pub2 -
The effects of synbiotics on indoxyl sulphate level, constipation, and quality of life associated with constipation in chronic haemodialysis patients: a randomized controlled trial.
Lydia A, Indra TA, Rizka A, Abdullah M. · · 2022 · cited 19× · PMID 35869437 · DOI 10.1186/s12882-022-02890-9
Verify or expand the search:
- PubMed search for NCT04527640
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Indonesia University trials
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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 NCT04527640 (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 Indonesia University
- Last refreshed: 28 August 2020
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/NCT04527640.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing