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Antibiotic

Low Dose Rifaximin DER for Sickle Cell Disease

Phase 2
Waitlist Available
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29
Awards & highlights

Study Summary

This trial is testing a new drug for sickle cell disease. 60 people will be enrolled, half taking the new drug and half taking a placebo. The trial will last for 3 months.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum plasma concentration

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose Rifaximin ERExperimental Treatment1 Intervention
twice daily
Group II: Low Dose Rifaximin DERExperimental Treatment1 Intervention
twice daily
Group III: High Dose Rifaximin ERExperimental Treatment1 Intervention
twice daily
Group IV: High Dose Rifaximin DERExperimental Treatment1 Intervention
twice daily
Group V: PlaceboPlacebo Group1 Intervention
twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Dose Rifaximin DER
2022
Completed Phase 2
~50
Low Dose Rifaximin ER
2022
Completed Phase 2
~50
Low Dose Rifaximin DER
2022
Completed Phase 2
~50
High Dose Rifaximin ER
2022
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,984 Total Patients Enrolled
Anya LoncaricStudy DirectorBausch Health
39 Previous Clinical Trials
20,787 Total Patients Enrolled
Varsha BhattStudy DirectorBausch Health
8 Previous Clinical Trials
995 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for inclusion in this medical experiment?

"This medical study seeks 60 qualified volunteers who are between eighteen and seventy years old, have anemia due to sickle cell disease (SCD) of any genotype, possess a documented Absolute Neutrophil Count of at least 1.0 x 109/L, Platelets of 75 x 109/L or more, Glomerular filtration rate 45 mL/min/1.73 m2 as determined by the CKD-EPI formula, Total bilirubin count no higher than 15 mg/dL, and experienced two Vaso-Occlusive Crises within 12 months prior to Screening. Furthermore,"

Answered by AI

How is Low Dose Rifaximin DER typically utilized to benefit patients?

"Rifaximin DER, administered in low doses, is frequently used to prevent clostridium difficile infection recurrence. It may also help treat bacterial infections and gastrointestinal conditions such as irritable bowel syndrome (IBS) or diarrhea."

Answered by AI

How many individuals are engaging in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical experiment is presently enrolling volunteers and has been doing so since March 22nd 2022. The most recent update was on August 29th of the same year, with a total of 60 participants sought from 3 trial hubs."

Answered by AI

Are there documented precedents for a Low Dose Rifaximin DER trial?

"In 2009, Low Dose Rifaximin DER was first studied at the New mexico VA Healthcare System. Since then, 18369 research trials have been completed and 23 are currently running with a concentration in Atlanta, Georgia."

Answered by AI

Has the FDA sanctioned Low Dose Rifaximin DER for therapeutic use?

"Given the Phase 2 nature of this trial, there is a sufficient amount of evidence to suggest that Low Dose Rifaximin DER has an acceptable level of safety; thus it received a score of 2."

Answered by AI

Does this clinical research accept individuals aged 25 or more?

"According to the prerequisites for enrollment, adults aged 18-70 are welcome to take part in this trial."

Answered by AI

Has enrollment for this experiment begun?

"Affirmative. Per the data present on clinicaltrials.gov, enrollment for this medical trial is currently open as of August 29th 2022. Initially posted in March 22nd 2022, 60 individuals are sought from 3 different locations to join the study."

Answered by AI
~15 spots leftby Apr 2025