Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 75 years old
• People with a body mass index (a measure of body weight relative to height) between 25 and 42
• People who have been diagnosed with a liver condition called MASLD, confirmed by a specific liver scan (FibroScan®) showing a result above 268 dB/m
• People with elevated liver enzyme levels in their blood (specific thresholds differ for males and females)
• People who have at least three features of metabolic syndrome — a cluster of conditions that includes a large waist measurement, high fasting blood sugar, raised HbA1c (a measure of longer-term blood sugar), a diagnosis of or treatment for type 2 diabetes, high blood pressure, high triglycerides (a type of fat in the blood), or low HDL ("good") cholesterol
• People whose weight has been stable (changing less than 4% either way) over the past 3 months
• People whose medications or supplements for ongoing health conditions have remained unchanged for at least 3 months before the study (bile salt sequestrant medications are not permitted)
• People who are not planning to change their diet or lifestyle habits during the study
• People who are willing and able to give informed consent and follow the study procedures

Who may not be able to join:

• People with a liver scarring (fibrosis) score of F2 or higher, measured at 8.0 kPa or above on FibroScan®
• People with a history of hepatitis A, B, or C (acute or chronic), autoimmune hepatitis, liver disease caused by medications, or severe liver disease
• People who have previously had or are waiting for a liver transplant
• People with type 1 diabetes
• People with poorly controlled type 2 diabetes (HbA1c above 8%)
• People with very high triglyceride levels (above 350 mg/dl)
• People living with HIV
• People diagnosed with hemochromatosis (a condition causing the body to store too much iron)
• People currently taking certain medications including pioglitazone, SGLT-2 inhibitors, or any approved drugs for MASLD or liver inflammation, within the past 8 weeks
• People currently taking bile salt sequestrant medications within the past 8 weeks
• People with significant gut conditions such as inflammatory bowel disease, short bowel syndrome, ongoing or recurring diarrhoea, or coeliac disease
• People with pancreatic failure or problems with the bile duct (including previous gallbladder removal or abnormal bilirubin levels in the blood)
• People with thyroid problems, as assessed by the trial investigator
• People with a history of heart disease (including heart attack, heart failure, stroke, or circulation problems in the legs or feet)
• People with a history of cancer or who take medications that suppress the immune system
• People who have had gastrointestinal surgery in the past year (appendix removal is an exception)
• People with a history of heavy or ongoing alcohol use (more than 14 units per week for females, more than 21 units per week for males)
• People who smoke heavily (more than 20 cigarettes per day)
• People who regularly take other probiotic products (more than 3 days per week), including probiotic food products such as Activia® or Actimel®
• People who have regularly taken certain supplements affecting liver function — such as omega-3 fatty acids above 500 mg/day, high-dose vitamin E, or milk thistle extract — in the 15 days before the study
• People currently taking a range of specific medications including corticosteroids, certain blood thinners, certain antidepressants or antipsychotics, and several others (confirm full medication list with trial site)
• People who have taken oral or injected antibiotics for more than 3 days in the month before the study begins
• People who regularly use laxatives
• People with serious ongoing illnesses such as advanced liver or kidney disease, severe depression, psychotic conditions, or neurological diseases
• People who are currently pregnant or planning to become pregnant during the study
• People who are breastfeeding at the time of eligibility assessment
• People who have taken part in another clinical trial within the past 6 months

Important: Always verify eligibility with the trial site directly before applying.