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NCT07898839

PHASE2

FEAST and HOPE: Redox PSC Pilot Study

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test whether a type of cell death called disulfidptosis plays a role in primary sclerosing cholangitis (PSC) in adults aged 18 to 70. Researchers will do this by giving participants a study diet and four oral agents designed to block disulfidptosis, then checking whether liver blood tests change. This study is not designed to show that the combination treats PSC. PSC is a long-term liver disease. In PSC, the bile ducts become inflamed and scarred over time. Bile ducts are small tubes that carry bile from the liver to the gut. Researchers are testing a new idea about why bile duct cells are damaged in PSC. Cells need a balance of certain sulfur-containing building blocks and the energy to process them. When this balance breaks down, proteins inside the cell can stick together the wrong way. This can cause the cell's inner structure to collapse, and the cell dies. This type of cell death is called disulfidptosis. Researchers think disulfidptosis may contribute to bile duct damage in PSC. This is a proof-of-principle study. This means it is an early, small study to test whether this idea is correct and worth studying further. Participants will follow a study diet and take four oral agents. Each agent was chosen because it may help protect cells from disulfidptosis: Alpha-lipoic acid (ALA), a natural antioxidant that helps cells manage stress N-acetylcysteine (NAC), which helps the body make glutathione, a natural antioxidant Nicotinamide riboside (NR), a form of vitamin B3 that helps cells make energy Metformin, a common diabetes medicine that changes how cells use sugar and energy The main questions it aims to answer are: 1. Does blocking disulfidptosis with the study diet and agents lower alkaline phosphatase (ALP)? ALP is a liver blood test that is often high in people with PSC. 2. Does it change other blood markers of liver health and inflammation? 3. What medical problems do participants have while on the study diet and agents? There is no comparison group in this study. All participants will receive the study diet and all four agents. Participants will: 1. Have a screening visit to check if they can join the study 2. Follow a study diet for the length of the study, with guidance from study dietitians 3. Receive help from the study to buy groceries that fit the study diet 4. Take photos of their meals and snacks using a phone app, so dietitians can review what they eat and give advice 5. Take the four study agents by mouth each day, starting at lower doses that are raised step by step over the first weeks 6. Visit the clinic in Boston about 11 times over about 18 weeks 7. Give blood samples at study visits to check liver tests, safety tests, and other markers 8. Answer questions about their health, symptoms, and any side effects Researchers will watch closely for side effects throughout the study. If liver tests rise too much, researchers will follow set safety steps, which may include stopping one or more study agents. About 15 people will take part.

Official title: FEAST and HOPE: Redox PSC Pilot Study in PSC

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01

Completion Date

2029-06

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Primary Sclerosing Cholangitis (PSC)

Interventions

DIETARY_SUPPLEMENT

N-Acetyl Cysteine (NAC)

N-acetylcysteine (NAC) capsules (Pure Encapsulations), taken orally. Dose: 1200 mg/day through Week 16. Selected as a precursor of glutathione to support cellular thiol and redox balance as part of a regimen targeting disulfidptosis.

DIETARY_SUPPLEMENT

Alpha-Lipoic Acid (ALA)

Alpha-lipoic acid (ALA) capsules (Pure Encapsulations), taken orally. Dose: 600 mg once daily in Week 0, then 600 mg twice daily from Week 1 through Week 16. Selected to support cellular antioxidant capacity and redox balance as part of a regimen targeting disulfidptosis.

DIETARY_SUPPLEMENT

Nicotinamide Riboside (NR)

Nicotinamide riboside (NR) chloride 250 mg capsules (Tru Niagen, ChromaDex), taken orally. Dose: 500 mg twice daily (1,000 mg/day) through Week 16. Selected as an NAD+ precursor to support cellular NADPH availability as part of a regimen targeting disulfidptosis.

DRUG

Metformin Hydrochloride Extended-Release Tablets

Metformin hydrochloride extended-release 500 mg tablets (Granules Pharmaceuticals), taken orally. Dose titrated per protocol to 1000 mg through Week 16. Selected for its effects on cellular glucose and energy metabolism as part of a regimen targeting disulfidptosis.

OTHER

Study Diet

Participants follow a protocol-specified study diet from Baseline through Week 16, guided by study dietitians. Dietary intake is recorded through meal photographs using the MetaBite for Research app, which dietitians review to provide individualized recommendations. Participants receive grocery support to facilitate adherence.

Inclusion Criteria: * Males and females aged 18 to 70 years * Ulcerative colitis (UC) duration of at least 6 months, with diagnosis confirmed by typical endoscopic and histologic findings * Primary sclerosing cholangitis (PSC) duration of at least 6 months, with diagnosis confirmed by typical cholangiogram findings and no evidence of a secondary cause of sclerosing cholangitis * Simple Clinical Colitis Activity Index (SCCAI) of 5 or less * Serum alkaline phosphatase (ALP) greater than 1.33 times the upper limit of normal (ULN) * Platelet count greater than 150,000/mm³ * Albumin greater than 3.3 g/dL * Serum creatinine below ULN * For participants on ursodeoxycholic acid (UDCA): stable dose for at least 3 months before screening. For participants not on UDCA: no UDCA use for at least 3 months before screening * For participants on mesalamine or sulfasalazine: stable dose for at least 4 weeks before enrollment * For participants on immunomodulators or biologic agents: stable dose for at least 8 weeks, and must remain on the same dose throughout the study * For participants on oral corticosteroids: dose no greater than 20 mg prednisone or 6 mg budesonide daily at enrollment * Willing and able to give informed consent before any study-specific procedures * Willing and able to comply with scheduled visits, laboratory tests, stool collection, and other study procedures Exclusion Criteria: * Pregnant, or positive pregnancy test at screening * Women of childbearing potential who intend to become pregnant during the study or within 1 month after the last dose of study medication * Currently breastfeeding, or intending to breastfeed during the study or within 1 month after the last dose of study medication * Women of childbearing potential unwilling to use protocol-specified contraception * Alanine aminotransferase (ALT) greater than 5 times ULN * Total bilirubin greater than 2 times ULN (unless history of Gilbert's syndrome) * International normalized ratio (INR) greater than 1.2 * Decompensated cirrhosis, defined by ascites, hepatic encephalopathy, or variceal bleeding * Small duct PSC * Secondary sclerosing cholangitis (e.g., due to chronic biliary obstruction, infection, ischemic injury, IgG4-related disease, drug- or toxin-induced cholangiopathy, or malignancy) * Other causes of liver disease, including viral, metabolic, alcohol-related, and other autoimmune liver diseases. Participants with non-alcoholic fatty liver disease may be included if there is no evidence of non-alcoholic steatohepatitis (NASH) * Positive antimitochondrial antibody (AMA) * History of liver transplantation * History of hepatocellular carcinoma or cholangiocarcinoma * Ascending cholangitis within 90 days of enrollment * Severe UC flare requiring intravenous corticosteroids within 3 weeks of enrollment or during the study, or anticipated new IBD medication within 3 months * History of colectomy, ileal pouch, or ostomy, or anticipated colectomy within the next few months * Positive stool culture, ova and parasites, or C. difficile toxin within 2 months of enrollment * Use of antibiotics and/or probiotics within 6 weeks of enrollment, or planned use during the study * Use of total parenteral nutrition or exclusive enteral nutrition at enrollment or during the study * Current vegetarian or vegan diet * Inability to complete a dietary log * Participation in another therapeutic clinical trial within 30 days or 5 half-lives of the other study drug (whichever is longer) before screening, or concurrent participation in another therapeutic trial * Any laboratory abnormality or condition that, in the investigator's opinion, could affect participant safety or the assessment of study results * Current use of metformin, use within 8 weeks before enrollment, or anticipated start of metformin outside the study * Estimated glomerular filtration rate (eGFR) below 50 mL/min/1.73 m² at screening * Confirmed diagnosis of diabetes mellitus * Known hypersensitivity to alpha-lipoic acid, N-acetylcysteine, nicotinamide riboside, metformin, or any excipient or capsule component of the study products

Clinical Research Directory

FEAST and HOPE: Redox PSC Pilot Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria