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NCT04495972
Intestinimonas for Prevention of Type 2 Diabetes Mellitus
NA trial testing Intestinimonas-capsules in PreDiabetes in 26 participants. Completed in 10 November 2023.
12 September 2023
Quick facts
| Lead sponsor | Caelus Pharmaceuticals BV |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 15 January 2021 |
| Primary completion | 12 September 2023 |
| Estimated completion | 10 November 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Intestinimonas-capsules
- Placebo-capsules
Conditions studied
- PreDiabetes — all drugs for PreDiabetes →
Sponsor
Caelus Pharmaceuticals BV
Who can join
Adults 18 to 65, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Modulating the Microbiota as a Therapeutic Intervention for Type 2 Diabetes.
Huda MN, Kim M, Bennett BJ. · · 2021 · cited 89× · PMID 33897618 · DOI 10.3389/fendo.2021.632335 -
Multimatrix Detection and Quantification of the Advanced Glycation End Products Precursor Fructoselysine via UHPLC-HRMS/MS.
Fenizia S, Manfredi M, Antoniotti V, Tini S, et al · · 2026 · PMID 41590686 · DOI 10.3390/metabo16010078
Verify or expand the search:
- PubMed search for NCT04495972
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related 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 NCT04495972 (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 Caelus Pharmaceuticals BV
- Last refreshed: 13 November 2023
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/NCT04495972.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing