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NCT03719729
Rifaximin to Modify the Disease Course in Sickle Cell Disease
Phase 2 trial testing Rifaximin in Sickle Cell Disease in 20 participants. Status unknown.
22 February 2020
Quick facts
| Lead sponsor | New York Medical College |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 22 August 2018 |
| Primary completion | 22 February 2020 |
| Estimated completion | 22 July 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rifaximin (rifaximin) — full drug profile →
Conditions studied
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
- Antibiotics — all drugs for Antibiotics →
Sponsor
New York Medical College
Who can join
Adults 18 to 70, any sex, with Sickle Cell Disease or Antibiotics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this single-arm, one-stage Phase II study, the investigators hypothesize that gut decontamination with rifaximin will reduce the frequency of hospital admission due to painful crisis in patients with SCD. The study will accrue 20 SCD patients who had at least two hospital admissions in the previous 12 months. These patients will receive rifaximin 550 mg twice a day for a total of 12 months. This following clinical parameters will be measured: 1. Changes in the annual rate of hospital admissions due to painful crisis; 2. Changes in the annual rate of days hospitalized; 3. Annual rates of uncomplicated crises; 4. Annual rate of acute chest syndrome; 5. Changes in the quality of life; and 6). Toxicities. The following laboratory parameters will be measured: 1. Changes in the number of circulating activated neutrophils; 2. Changes in the intestinal microbiome diversity; 3. Changes in the urinary 3-indoxyl sulfate levels; 4. Changes in the serum biomarkers of intestinal permeability (lipopolysaccharides; zonulin, citrulline, and fatty acid binding proteins).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging disease-modifying therapies for sickle cell disease.
Carden MA, Little J. · · 2019 · cited 60× · PMID 31413089 · DOI 10.3324/haematol.2018.207357 -
Drug Therapies for the Management of Sickle Cell Disease.
Rai P, Ataga KI. · · 2020 · cited 32× · PMID 32765834 · DOI 10.12688/f1000research.22433.1 -
Management of Older Adults with Sickle Cell Disease: Considerations for Current and Emerging Therapies.
Oyedeji CI, Hodulik KL, Telen MJ, Strouse JJ. · · 2023 · cited 7× · PMID 36853587 · DOI 10.1007/s40266-023-01014-8
Verify or expand the search:
- PubMed search for NCT03719729
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other New York Medical College trials
Trials by the same sponsor.
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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 NCT03719729 (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 New York Medical College
- Last refreshed: 14 March 2019
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/NCT03719729.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing