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NCT03797131
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
NA trial testing KB195 (a novel mixture of oligosaccharides) in Urea Cycle Disorders in 4 participants. Completed in 1 September 2019.
1 September 2019
Quick facts
| Lead sponsor | Kaleido Biosciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 4 |
| Start date | 6 January 2019 |
| Primary completion | 1 September 2019 |
| Estimated completion | 1 September 2019 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- KB195 (a novel mixture of oligosaccharides)
Conditions studied
- Urea Cycle Disorders — all drugs for Urea Cycle Disorders →
Sponsor
Kaleido Biosciences — full company profile →
Who can join
14 and older, any sex, with Urea Cycle Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs). This will be done using a stable isotope to assess nitrogen metabolism in the blood, urine, and stool. The study will also assess the safety and tolerability of KB195 in patients with UCDs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03797131
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Urea Cycle Disorders
Currently open trials in the same condition.
- NCT05671666 — Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients · NA · recruiting
Other Kaleido Biosciences trials
Trials by the same sponsor.
- NCT04814914 — An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or · completed
- NCT04486482 — A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Fu · NA · completed
- NCT04508413 — A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and · NA · completed
- NCT04414124 — A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients · NA · completed
- NCT03933410 — UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder · Phase 2 · terminated
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 NCT03797131 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kaleido Biosciences
- Last refreshed: 10 January 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/NCT03797131.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing