Metabolic dysfunction associated steatotic liver disease (MASLD) NAFLD
Conditions
Interventions
Participants will be given placebo or 10^9 colony forming units (CFU)/ml of
oral D. piger once daily for 4 weeks (n=10 per arm, total of 20 participants).
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Increased waist circumference (>102 cm men, 88>cm women) - Insulin resistance (HOMA-IR >2,5) - 18-70 years
Exclusion criteria
Exclusion criteria: - Use of systemic medication (except for paracetamol), including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period. - A history of a cardiovascular event - A history of cholecystectomy - Overt untreated gastrointestinal disease or abnormal bowel habits - Liver enzymes>2.5*fold higher than the upper limit of normal range - Smoking - Alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal outcome will be patient safety and tolerability (biochemical parameters of kidney and liver function and complete blood count, adverse events as compared to placebo) and engraftment of D. piger in the gut as compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to fructose challenge test during fomepizol infusion (including fructose metabolites in blood, feces, urine and breath) Transcriptomics in duodenal biopsies Microbiome compostion (fecal shotgun metagenomics) Fructose metabolites in 24 feces and 24h urine Quality of Life questionnaires Alcohol production per gram feces using bioreactor analyses Glycemic control using continuous glucose monitoring Liver fat, assessed using MRI liver and Fibroscan (V2 and V5) | — |
Countries
Netherlands
Outcome results
None listed