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NCT01414010
Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome
NA trial testing Trametes versicolor extract in Human Gut Microbiota in 32 participants. Completed in 1 February 2012.
1 February 2012
Quick facts
| Lead sponsor | Beth Israel Deaconess Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 1 August 2011 |
| Primary completion | 1 February 2012 |
| Estimated completion | 1 February 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Trametes versicolor extract
- Saccharomyces boulardii — full drug profile →
- Amoxicillin (amoxicillin) — full drug profile →
Conditions studied
- Human Gut Microbiota — all drugs for Human Gut Microbiota →
Sponsor
Beth Israel Deaconess Medical Center
Who can join
Adults 18 to 39, any sex, with Human Gut Microbiota. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Bacteria Prevalence in Stool
Time frame: Day 0 to 56
The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56
Sponsor's own description
The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers. It is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Narrative Review: Bioactive Potential of Various Mushrooms as the Treasure of Versatile Therapeutic Natural Product.
Chopra H, Mishra AK, Baig AA, Mohanta TK, et al · · 2021 · cited 33× · PMID 34575766 · DOI 10.3390/jof7090728
Verify or expand the search:
- PubMed search for NCT01414010
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01414010 (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 Beth Israel Deaconess Medical Center
- Last refreshed: 25 June 2017
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/NCT01414010.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing