Alcohol ConsumptionNCT02654236
Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling
A study testing 10 mg Obeticholic Acid (OCA) in people with Alcohol Consumption, run by Suthat Liangpunsakul at 1 site in United States.
Trial summary
The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- 10 mg Obeticholic Acid (OCA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals ≥ 21 to 65 years old
- Able to provide informed consent \& negative urine pregnancy test where appropriate
- Healthy controls must have not consumed any alcohol within 3 months prior to the screening visit
- Heavy alcohol drinking is defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months
- Women of child bearing potential should be willing to practice contraception throughout the treatment period
Who cannot join
- Active infection as evidenced by positive urine culture, blood culture, or pneumonia
- Serum creatinine > 1.5 mg/dL
- Known co-existing infection with hepatitis C, hepatitis B, or HIV
- Significant systemic or major illness including COPD, CHF and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study.
- Participation in another investigational drug, biologic, or medical device trial within 30 days prior to Screening
- Previous history of jaundice or signs of liver diseases such as spider angiomata, ascites, or history of esophageal varices or hepatic encephalopathy
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- Total bilirubin > 2 mg/dl and INR > 1.5 Page 20 of 37
- Women who are pregnant or nursing
- Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
- Subjects who are taking warfarin
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.
- Conditions
- Alcohol Consumption
- Being tested
- Placebo, 10 mg Obeticholic Acid (OCA)
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
10 mg Obeticholic Acid (OCA)Drug
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Heavy Drinkers on placebo Receives: Drug: Placebo |
| 10 mg Obeticholic Acid (OCA) | Experimental | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks. Receives: Drug: 10 mg Obeticholic Acid (OCA) |
| Non-drinking Controls | No intervention | Non-drinking healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
Measured: Baseline to 28 days
Change in FGF19 Levels to Determine Effect of FXR
Measured: Baseline to 28 days
Secondary outcomes (11)
Change in Fasting Serum Bile Salt Levels
Measured: Baseline to 28 days
Change in Oxidative Stress Level by Measuring Malondialdehyde
Measured: Baseline to 28 days
Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance
Measured: Baseline to 28 days
Change in Gut Permeability Through Lactulose/Mannitol Test
This is the measurement to quantify two non-metabolized sugar molecules-lactulose and mannitol-to determine the gut permeability
Measured: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Plasma LPS
Measured: Baseline to 28 days
Change in Intestinal Inflammation by Measuring Stool Calprotectin
Measured: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of TNF-alpha
Measured: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Serum sCD14
Measured: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-6
Measured: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-8
Measured: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-1
Measured: Baseline to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol ConsumptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suthat Liangpunsakul
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Intercept Pharmaceuticals
- Responsible party
- Sponsor-investigator, Suthat Liangpunsakul, Indiana University
- Investigators
- Suthat Liangpunsakul, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654236
- Sponsor's protocol ID
- TREAT 005
- Status last verified
- Apr 2023
- First submitted
- 6 Jan 2016
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling
- ClinicalTrials.gov ID
- NCT02654236
- Acronym / sponsor ID
- TREAT 005
- Conditions
- Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suthat LiangpunsakulUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Intercept Pharmaceuticals
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 25 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboHeavy Drinkers on placebo |
| 10 mg Obeticholic Acid (OCA) | Experimental | Drug: 10 mg Obeticholic Acid (OCA)10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks. |
| Non-drinking Controls | No intervention | –Non-drinking healthy controls |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals ≥ 21 to 65 years old
- Able to provide informed consent \& negative urine pregnancy test where appropriate
- Healthy controls must have not consumed any alcohol within 3 months prior to the screening visit
- Heavy alcohol drinking is defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months
- Women of child bearing potential should be willing to practice contraception throughout the treatment period
Key exclusion criteria (10 listed)
- Active infection as evidenced by positive urine culture, blood culture, or pneumonia
- Serum creatinine > 1.5 mg/dL
- Known co-existing infection with hepatitis C, hepatitis B, or HIV
- Significant systemic or major illness including COPD, CHF and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study.
- Participation in another investigational drug, biologic, or medical device trial within 30 days prior to Screening
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 |
|---|---|---|
| Placebo1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks. | Drug | Placebo |
| 10 mg Obeticholic Acid (OCA)10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks. | Drug | 10 mg Obeticholic Acid (OCA) |
Primary outcome
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
Time frame: Baseline to 28 days
Change in FGF19 Levels to Determine Effect of FXR
Time frame: Baseline to 28 days
11 secondary outcomes
Change in Fasting Serum Bile Salt Levels
Time frame: Baseline to 28 days
Change in Oxidative Stress Level by Measuring Malondialdehyde
Time frame: Baseline to 28 days
Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance
Time frame: Baseline to 28 days
Change in Gut Permeability Through Lactulose/Mannitol Test
Time frame: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Plasma LPS
Time frame: Baseline to 28 days
Change in Intestinal Inflammation by Measuring Stool Calprotectin
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of TNF-alpha
Time frame: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Serum sCD14
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-6
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-8
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-1
Time frame: Baseline to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suthat Liangpunsakul, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 mg Obeticholic Acid (OCA) in people with Alcohol Consumption, run by Suthat Liangpunsakul 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 5 inclusion and 10 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 25 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR (time frame: Baseline to 28 days). The study lists 2 primary outcomes in all. 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 25 Apr 2023.