Trial reportUrolithiasis2018
A randomised Phase II/III study to evaluate the efficacy and safety of orally administered Oxalobacter formigenes to treat primary hyperoxaluria.
Trial report in Urolithiasis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
70 citing papers in PubMed, 2 syntheses or guidelines pooled it, 109 citations in OpenAlex.
- Nutrients, vitamins, probiotics and herbal products: an update of their role in urolithogenesis.Urolithiasis · 2020Pooled it
- Brazilian Guidelines on evaluation and clinical management of Nephrolithiasis: Brazilian Society of Nephrology.Jornal brasileiro de nefrologiaGuideline
- ePHex: a phase 3, double-blind, placebo-controlled, randomized study to evaluate long-term efficacy and safety of Oxalobacter formigenes in patients with primary hyperoxaluria.Pediatric nephrology (Berlin, Germany) · 2023Trial
- Plasma oxalate and eGFR are correlated in primary hyperoxaluria patients with maintained kidney function-data from three placebo-controlled studies.Pediatric nephrology (Berlin, Germany) · 2021Trial
- Acute renal failure after dietary change - a case report.BMC nephrology · 2026Article
- [Reduced intestinal abundance ofNan fang yi ke da xue xue bao = Journal of Southern Medical University · 2025Article
- Body mass index mediates the association between the dietary index for gut microbiota and kidney stones: a cross-sectional study.BMC public health · 2025Article
- Microbiota and kidney disease: the road ahead.Nature reviews. Nephrology · 2025Review
- Hyperoxaluria: Diagnosis and Treatment.The Urologic clinics of North America · 2025Review
- InducingKidney international reports · 2025Article
- Review
- Probiotics in the prevention and treatment of calcium oxalate kidney stones: mechanisms and therapeutic potential.Frontiers in microbiology · 2025Review
- Potassium sodium hydrogen citrate intervention on gut microbiota and clinical features in uric acid stone patients.Applied microbiology and biotechnology · 2024Article
- Opportunities in Primary and Enteric Hyperoxaluria at the Cross-Roads Between the Clinic and Laboratory.Kidney international reports · 2024Article
- Non-lactic acid bacteria probiotics isolated from intestine or various circumstances.Food science and biotechnology · 2024Review
- Infant primary hyperoxaluria type 1Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024Review
- Engineered microorganisms: A new direction in kidney stone prevention and treatment.Synthetic and systems biotechnology · 2024Review
- Navigating the Evolving Landscape of Primary Hyperoxaluria: Traditional Management Defied by the Rise of Novel Molecular Drugs.Biomolecules · 2024Review
- Understanding formation processes of calcareous nephrolithiasis in renal interstitium and tubule lumen.Journal of cellular and molecular medicine · 2024Review
- Therapeutic effects of probiotics and herbal medications on oxalate nephrolithiasis: a mini systematic review.Iranian journal of microbiology · 2024Review
10 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Primary hyperoxaluria (PH) patients overproduce oxalate because of rare genetic errors in glyoxylate metabolism. Recurrent urolithiasis and/or progressive nephrocalcinosis are PH hallmarks and can lead to kidney damage, systemic oxalosis and death. Based on previous studies, we hypothesised that treatment with the oxalate-metabolizing bacterium Oxalobacter formigenes would mediate active elimination of oxalate from the plasma to the intestine of PH patients, thereby reducing urinary oxalate excretion (Uox). The efficacy and safety of O. formigenes (Oxabact™ OC3) were evaluated for 24 weeks in a randomised, placebo-controlled, double-blind study. The primary endpoint was reduction in Uox. Secondary endpoints included change in plasma oxalate (Pox) concentration, frequency of stone events, number of responders, and Uox in several subgroups. Additional post hoc analyses were conducted. Thirty-six patients were randomised; two patients withdrew from placebo treatment. Both OC3 and placebo groups demonstrated a decrease in Uox/urinary creatinine ratio, but the difference was not statistically significant. No differences were observed with respect to change in Pox concentration, stone events, responders' number or safety measures. In patients with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.