Effect of 4 weeks of oral D. piger on safety, pharmacokinetics and ethanol metabolism in overweight individuals (2023)

Conditions: Metabolic dysfunction associated steatotic liver disease (MASLD)
NAFLD
10019654

Registration Number: NL-OMON56584

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Increased waist circumference (>102 cm men, 88>cm women)
- Insulin resistance (HOMA-IR >2,5)
- 18-70 years

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The principal outcome will be patient safety and tolerability (biochemical<br /><br>parameters of kidney and liver function and complete blood count, adverse<br /><br>events as compared to placebo) and engraftment of D. piger in the gut as<br /><br>compared to placebo. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Response to fructose challenge test during fomepizol infusion (including<br /><br>fructose metabolites in blood, feces, urine and breath)<br /><br>Transcriptomics in duodenal biopsies<br /><br>Microbiome compostion (fecal shotgun metagenomics)<br /><br>Fructose metabolites in 24 feces and 24h urine<br /><br>Quality of Life questionnaires<br /><br>Alcohol production per gram feces using bioreactor analyses<br /><br>Glycemic control using continuous glucose monitoring<br /><br>Liver fat, assessed using MRI liver and Fibroscan (V2 and V5)</p><br>