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HMG-CoA Reductase Inhibitor

Rosuvastatin and Gut Microbiome in Healthy Subjects (INGEST Trial)

Phase 4
Waitlist Available
Led By Sony Tuteja, PharmD, MS
Research Sponsored by Sony Tuteja
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is aged 18 to 65 years. The gut microbiome has been shown to change gradually with time, although there is no cut-off in age when this occurs.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

INGEST Trial Summary

This trial will study how rosuvastatin affects gut bacteria and cholesterol levels. 100 healthy volunteers will be enrolled over 2 years, with 4 study visits during that time.

Who is the study for?
Healthy volunteers aged 18 to 65, without diabetes, hypothyroidism, cancer history, gut inflammation disorders like IBD or celiac disease. Must not have used antibiotics in the last 6 months or be current smokers. Participants should not have cardiovascular diseases, kidney/liver dysfunction, extreme BMI values (<18.5 or >30), bowel resection surgery (except appendectomy), abnormal bowel frequency, and must agree to use birth control.Check my eligibility
What is being tested?
The study is testing how rosuvastatin affects gut bacteria and cholesterol levels in healthy individuals over approximately 16 weeks with four visits. It will also explore how gut bacteria influence the drug's effectiveness at lowering cholesterol.See study design
What are the potential side effects?
Rosuvastatin may cause muscle pain, constipation or diarrhea, nausea, headache; however specific side effects related to changes in gut microbiome due to the drug are currently unknown and part of what this trial aims to discover.

INGEST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

INGEST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in bacterial abundance
Secondary outcome measures
Change in LDL-C
Other outcome measures
Change in fecal bile acid concentrations
Change in serum FGF19 levels

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03074630
8%
genital fungal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adverse Events

INGEST Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RosuvastatinExperimental Treatment1 Intervention
rosuvastatin 20 mg daily for eight weeks
Group II: PlaceboPlacebo Group1 Intervention
placebo daily for eight weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
2019
Completed Phase 4
~3150

Find a Location

Who is running the clinical trial?

Sony TutejaLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Sony Tuteja, PharmD, MSPrincipal Investigator - University of Pennsylvania
University of Pennsylvania
2 Previous Clinical Trials
825 Total Patients Enrolled

Media Library

Rosuvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098003 — Phase 4

Frequently Asked Questions

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

Who meets the specific inclusion criteria for this particular clinical trial?

"This study is open to 100 patients who are hs positive and between 18-65 years old. To qualify, potential patients must also be able to provide informed consent and have a healthy gut microbiome."

Answered by AI

What health conditions does Rosuvastatin help to treat?

"Rosuvastatin is an effective pharmaceutical treatment for hypertriglyceridemias, cardiovascular disease, and cardiovascular events."

Answered by AI

Are there any reports of serious adverse effects from taking Rosuvastatin?

"Rosuvastatin has been approved as a treatment, meaning that it is safe."

Answered by AI

Does this research project restrict participants to those under 40 years old?

"Eligibility for this study requires that potential patients are aged between 18 and 65."

Answered by AI

What is the efficacy of Rosuvastatin in other clinical trials?

"There are currently 42 live clinical trials studying Rosuvastatin. This includes 13 Phase 3 trials. Although Miami, Florida has a significant portion of the total trials, there are 328 locations running trials for this treatment globally."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Investigation of the Gut Microbiome and Statin Response
Sony Tuteja 2020. "Investigation of the Gut Microbiome and Statin Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04098003.
All > Microbiome
~1 spots leftby Jun 2024
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