Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea
Public ClinicalTrials.gov record NCT04192487. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Open Label Study to Assess the Safety and Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in People Living With HIV/AIDS (PLWHA) With Non-Infectious Diarrhea
Study identification
- NCT ID
- NCT04192487
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Napo Pharmaceuticals, Inc.
- Industry
- Enrollment
- 17 participants
Conditions and interventions
Conditions
Interventions
- Crofelemer delayed-release tablets 125mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2019
- Primary completion
- Aug 30, 2021
- Completion
- Aug 30, 2021
- Last update posted
- Oct 21, 2021
2019 – 2021
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | — |
| Healthcare Advocates International | Stratford | Connecticut | 06615 | — |
| The Research Institute | Springfield | Massachusetts | 01105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04192487, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2021 · Synced May 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04192487 live on ClinicalTrials.gov.