Non-Alcoholic Fatty Liver DiseaseMODIFYNCT05209100
Microbiome-Mediated Gut Dysfunction in Non-Alcoholic Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
This study is designed to generate the first human evidence to date on microbiota encroachment in non-alcoholic fatty liver disease. In parallel, the investigators will establish a biobank that will allow future studies to reveal how encroachment is connected to host metabolism and liver physiology, including the… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Sigmoidoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 22 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals will be age 35-65, obese (BMI 27.5-39.9 kg/m2), and weight stable. Age is a microbiome modifier, particularly beyond age 65. This is why our upper age limit is 65. Young individuals are also less likely to have NAFLD, thus our starting age is 35. The investigators will exclude individuals with a history of other forms of liver disease, bariatric surgery, or other relevant contraindications to participation.
Who may be able to join
- Age 35-65 years
- Weight stable (weight change of no more than 3 kg + 0.5 kg) during the 6 months prior to enrollment
- Fasting triglycerides ≤400 mg/dL
- Body mass index (BMI) 27.5-39.9 kg/m2
- Able to speak and understand written and spoken English
- Understands the procedures and agrees to participate by giving written informed consent
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- Willing and able to comply with scheduled visits, laboratory tests, and other study procedures
- Magnetic Resonance Imaging Proton Density Fat Fraction Criteria:
- Controls: <5%
- Steatosis Only: ≥5.6%
- Fibrosis: no specific percentage required
- Magnetic Resonance Elastography Criteria:
- Controls: < 2.50 kPa
- Steatosis Only: <2.50 kPa
- Fibrosis (without cirrhosis): >2.61 - < 4.69 kPa
Who cannot join
- Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:
- Diagnosis of type 1 or type 2 diabetes mellitus
- Insulin use
- Treatment with pioglitazone or metformin
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within the previous 6 months (1 drink = 5 ounces [150 mL] of wine, 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor)
- A total score of ≥8 on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire, indicating harmful or hazardous alcohol consumption
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- Clinical evidence of hepatic decompensation, including, but not limited to esophageal varices, ascites, or hepatic encephalopathy.
- Evidence of other forms of chronic liver disease (including laboratory tests and confirmed with a single repeat, if needed):
- Hepatitis B virus: defined by presence of hepatitis B surface antigen
- Hepatitis C virus: As defined by a clinical history of previous diagnosis of Hepatitis C (treated or untreated) or a positive Hepatitis C antibody.
- Known diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndrome
- Alcoholic liver disease
- Known diagnosis of hemochromatosis
- Prior known drug-induced liver injury
- Known or suspected hepatocellular carcinoma or other liver cancer
- History of liver transplant, current placement on a liver transplant list, or current model of end-stage liver disease (MELD) score >12
- Histological presence of cirrhosis on a prior biopsy
- Bleeding disorders
- Current treatment of blood thinners or antiplatelet medications that cannot be safely stopped for biopsy procedure.
- Acute or chronic infections
- Severe asthma or chronic obstructive pulmonary disease
- Renal insufficiency or nephritis
- Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
- Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
- Prior or planned bariatric surgery
- Gastrointestinal disorders including: inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis.
- A positive urine drug test for illicit drugs
- History of major depression within < 5 years from screening or which, in the opinion of a medical provider, will impact the participant's ability to complete the study.
- History of eating disorders
- History of Cushing's disease or syndrome
- Active rheumatoid arthritis or other inflammatory rheumatic disorder
- Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of Biopsy Visit.
- Nicotine use within the past 3 months
- Major surgery within 4 weeks prior to Screening.
- Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women) during screening
- Participation in studies involving investigational drug(s) within 30 days prior to Screening
- History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator)
- Human Immunodeficiency Virus (HIV) infection defined as: previous diagnosis of HIV infection, history of positive screening or quantitative HIV testing; positive HIV screen
- Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years)
- Use of antibiotics within 3 months of screening
- Use of drugs historically associated with non-alcoholic fatty liver disease (NAFLD) for ≥1 month in the previous year prior to Screening; examples include: amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins
- Participants who fulfill any of the contraindications for MRI; examples include metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos
- Unable to participate in MR assessments due to physical limitations or equipment tolerances (e.g., MRI bore size and 500-pound weight limit) based on Investigator's judgment at screening
- Any person with history of severe claustrophobia or unable to lie still within the environment of the MRI scanner or unable maintain a breath hold for the required period to acquire images without mild sedation/treatment with an anxiolytic
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening (participants may not donate blood any time during the study, through the final study day)
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days.
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
Official title: A Case-Control, Observational, Proof of Mechanism Study to Define Microbiome-Mediated Gut Dysfunction Across the Spectrum of Non-Alcoholic Fatty Liver Disease
This study is designed to generate the first human evidence to date on microbiota encroachment in non-alcoholic fatty liver disease. In parallel, the investigators will establish a biobank that will allow future studies to reveal how encroachment is connected to host metabolism and liver physiology, including the composition and function of the fecal microbiome.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Sigmoidoscopy
- Keywords
- Microbiome, steatosis, fibrosis, obesity
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Fibrosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SigmoidoscopyProcedure or surgery
During the sigmoidoscopy, biopsy tissue will be obtained for research purposes. Biopsies will be performed based on typical standard of care procedures without an antecedent bowel prep.
| Study group | Role | What they receive |
|---|---|---|
| Normal Liver | Individuals will have no evidence of steatosis or fibrosis. Receives: Procedure: Sigmoidoscopy | |
| Steatosis Only | Individuals will have at least 5.6% liver fat as assessed by magnetic resonance imaging proton density fat fraction with no evidence of fibrosis as evidenced by magnetic resonance elastography. Receives: Procedure: Sigmoidoscopy | |
| Fibrosis without Cirrhosis | Individuals will have any level of liver fat as assessed by magnetic resonance imaging proton density fat fraction with fibrosis up to level F3 as evidenced by magnetic resonance elastography. Receives: Procedure: Sigmoidoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Encroachment
Measured via a combination of in situ hybridization and confocal microscopy to measure the distance of microbes from intestinal epithelial cells
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start11 Feb 2022
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Corbin, PhD, RD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209100
- Sponsor's protocol ID
- 1584959
- Acronym
- MODIFY
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control, Observational, Proof of Mechanism Study to Define Microbiome-Mediated Gut Dysfunction Across the Spectrum of Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05209100
- Acronym / sponsor ID
- MODIFY / 1584959
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Microbiome, steatosis, fibrosis, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to generate the first human evidence to date on microbiota encroachment in non-alcoholic fatty liver disease. In parallel, the investigators will establish a biobank that will allow future studies to reveal how encroachment is connected to host metabolism and liver physiology, including the composition and function of the fecal microbiome.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Liver | – | Procedure: SigmoidoscopyIndividuals will have no evidence of steatosis or fibrosis. |
| Steatosis Only | – | Procedure: SigmoidoscopyIndividuals will have at least 5.6% liver fat as assessed by magnetic resonance imaging proton density fat fraction with no evidence of fibrosis as evidenced by magnetic resonance elastography. |
| Fibrosis without Cirrhosis | – | Procedure: SigmoidoscopyIndividuals will have any level of liver fat as assessed by magnetic resonance imaging proton density fat fraction with fibrosis up to level F3 as evidenced by magnetic resonance elastography. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals will be age 35-65, obese (BMI 27.5-39.9 kg/m2), and weight stable. Age is a microbiome modifier, particularly beyond age 65. This is why our upper age limit is 65. Young individuals are also less likely to have NAFLD, thus our starting age is 35. The investigators will exclude individuals with a history of other forms of liver disease, bariatric surgery, or other relevant contraindications to participation.
Key inclusion criteria (15 listed)
- Age 35-65 years
- Weight stable (weight change of no more than 3 kg + 0.5 kg) during the 6 months prior to enrollment
- Fasting triglycerides ≤400 mg/dL
- Body mass index (BMI) 27.5-39.9 kg/m2
- Able to speak and understand written and spoken English
Key exclusion criteria (46 listed)
- Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:
- Diagnosis of type 1 or type 2 diabetes mellitus
- Insulin use
- Treatment with pioglitazone or metformin
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within the previous 6 months (1 drink = 5 ounces [150 mL] of wine, 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SigmoidoscopyDuring the sigmoidoscopy, biopsy tissue will be obtained for research purposes. Biopsies will be performed based on typical standard of care procedures without an antecedent bowel prep. | Procedure or surgery | Fibrosis without Cirrhosis, Normal Liver, Steatosis Only |
Primary outcome
Microbiome Encroachment
Time frame: Baseline
Measured via a combination of in situ hybridization and confocal microscopy to measure the distance of microbes from intestinal epithelial cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- AdventHealth Translational Research InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Corbin, PhD, RD principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Encroachment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.