Trial reportPediatric nephrology (Berlin, Germany)2017
A randomised Phase I/II trial to evaluate the efficacy and safety of orally administered Oxalobacter formigenes to treat primary hyperoxaluria.
Trial report in Pediatric nephrology (Berlin, Germany), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 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
56 citing papers in PubMed, 2 syntheses or guidelines pooled it, 83 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
- A randomised Phase II/III study to evaluate the efficacy and safety of orally administered Oxalobacter formigenes to treat primary hyperoxaluria.Urolithiasis · 2018Trial
- Gut microbiota: a novel key player in urinary stone formation - from oxalate metabolism to systemic regulation.Gut microbes · 2026Review
- Animal Models of Hyperoxaluria and Their Relevance for Fundamental Research and Clinical Practice.International journal of molecular sciences · 2026Review
- Review
- 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
- OxDc-A0: an oral gastro-tolerant oxalate decarboxylase for treating secondary hyperoxaluria.Urolithiasis · 2025Article
- Review
- 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
- Engineered microorganisms: A new direction in kidney stone prevention and treatment.Synthetic and systems biotechnology · 2024Review
- Multiomics Assessment of the Gut Microbiome in Rare Hyperoxaluric Conditions.Kidney international reports · 2024Article
- 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
Corrections and comments
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Authors and funding
11 authors at 10 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPrimary hyperoxaluria (PH) is a rare, genetic disorder which involves the overproduction of endogenous oxalate, leading to hyperoxaluria, recurrent urolithiasis and/or progressive nephrocalcinosis and eventually resulting in kidney failure and systemic oxalosis. The aim of this trial was to investigate whether treatment involving an oxalate-metabolising bacterium (Oxalobacter formigenes) could reduce urinary oxalate excretion in PH patients.
methodsThe efficacy and safety of O. formigenes (Oxabact® OC5; OxThera AB, Stockholm, Sweden) was evaluated in a randomised, placebo-controlled, double-blind study for 8 weeks. The primary objective was reduction in urinary oxalate excretion (Uox). Secondary objectives included faecal O. formigenes count and decrease in plasma oxalate concentration (Pox).
resultsTwenty-eight patients randomised 1:1 to the treatment group (OC5) or the placebo group completed the study. After 8 weeks of treatment, there was no significant difference in the change in Uox (mmol/24 h/1.73 m
conclusionsTreatment with OC5 did not significantly reduce Uox or Pox over 8 weeks of treatment. The treatment was well tolerated and successfully delivered to the gastrointestinal tract.
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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.