Investigation of the Gut Microbiome and Statin Response

NCT04098003 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 832874
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

There is evidence that the bacteria that naturally reside in the gut can influence how well we respond to medications. Therefore this study will look at how rosuvastatin, a medication used to lower cholesterol levels, may change the bacteria in the gut. Investigators will also examine how the gut bacteria will affect the ability of rosuvastatin to lower cholesterol levels. There will be 4 study visits over the course of about 16 weeks.The expected duration of the study is 2 years. Investigators plan to enroll 100 healthy volunteers during that time.

Conditions

Healthy Volunteers

Keywords

gut microbiome; statins; cholesterol

Outcome Measures

Primary Outcomes (1)

• Change in bacterial abundance

  as measured by operational taxonomic units (OTUs)

  8 weeks

Secondary Outcomes (1)

• Change in LDL-C

  8 weeks

Other Outcomes (2)

• Change in fecal bile acid concentrations

  8 weeks

• Change in serum FGF19 levels

  8 weeks

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

rosuvastatin 20 mg daily for eight weeks

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

placebo daily for eight weeks

Drug: Placebo

Interventions

Rosuvastatin DRUG

rosuvastatin 20 mg daily or placebo for eight weeks

Also known as: Crestor

Rosuvastatin

Placebo DRUG

Matched placebo control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is capable of giving informed consent
• 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.

You may not qualify if:

• Participants with cardiovascular disease such as a history of heart failure (New York Heart Association class II-IV), myocardial infarction, stroke, coronary artery bypass graft, hypertension, and hyperlipidemia as these conditions are associated with altered gut microbiome composition.74 Hypertension is defined as blood pressure greater than 160/110 or on any anti-hypertensive medications. LDL-C \>190 mg/dl or \<100 mg/dl and triglycerides \> 400 mg/dl.
• Participants with a history of cancer.
• Kidney disease (serum creatinine \>1.5 mg/dl).
• Liver dysfunction (alanine aminotransferase \> 2 times the upper limit of normal).
• Diabetes mellitus (DM) - Diabetes itself may affect the gut microbiome although this has not been extensively studied. In addition to a prior diagnosis of diabetes mellitus other than that related to pregnancy, a fasting glucose level of greater than 125mg/dL will be used to exclude participation.
• Clinical diagnosis of hypothyroidism
• History of inflammatory disorders of the intestinal tract (i.e. IBD, celiac sprue).
• Use of antibiotics in the prior 6 months.
• Use of pre-, pro-, or synbiotics.
• Chronic medication use (including over the counter medications and herbal supplements) with the exception of oral contraceptives. Since we are evaluating the impact of rosuvastatin on the gut microbiome we would like to exclude the potential impact of confounding medications.
• Current smoker. The effect of smoking on the microbiome of the gut is unknown.
• Known history of alcohol or substance abuse.
• Unable to abstain from consumption of illicit drugs during the study period.
• Prior bowel resection surgery other than appendectomy. It is unknown how prior bowel resection surgery may influence the microbiome composition; hence we will exclude these participants.
• Baseline bowel frequency less than every 2 days or greater than 3 times daily. Normal bowel frequency is every 3rd day to 3 times per day. Although unknown, stool frequency could be related to the microbiome composition. To avoid the need for use of antidiarrheal medications or laxatives, which themselves could alter the microbiome composition, these patients will be excluded.

Sponsors & Collaborators

• Sony Tuteja: lead

Study Sites (1)

University of Pennsylvania

Phildelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sony Tuteja, PharmD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Matching placebo capsules will be formulated
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor of Medicine

Model Details: This is a randomized, placebo controlled, double blind (participant and outcomes assessor) trial to investigate the effects of rosuvastatin on the gut microbiome. Healthy volunteers will be randomized to rosuvastatin 20 mg daily or placebo for eight weeks in a 2:1 ratio.

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 20, 2019
• Study Start: February 6, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)