Actively Recruiting
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals
Led by Max Nieuwdorp · Updated on 2024-07-16
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of a probiotic called D. piger on intestinal ethanol production in overweight adults. This randomized, placebo-controlled trial aims to measure changes in ethanol levels in the blood and examine fecal samples to better understand how D. piger affects metabolism. The study focuses on adults with overweight who also have impaired glucose tolerance, exploring safety and pharmacokinetics over a 4-week period. Participants will be randomly assigned to receive either an oral suspension of D. piger or a placebo once daily for 30 days. The placebo contains glycerol and maltodextrin, while the D. piger suspension contains a specific concentration of the probiotic strain. Throughout the trial, participants will undergo a fructose challenge test combined with fomepizole, gastroduodenoscopy, MRI liver scans, and FibroScan at the start and end of the treatment period. Weekly safety visits will be held to monitor participant health. During the study, participants will attend regular visits for assessments including blood tests to monitor liver enzymes and other markers, analysis of intestinal microbiota, dietary questionnaires, and continuous glucose monitoring. Researchers will track primary outcomes such as gut engraftment of D. piger and any adverse events over 30 days. Secondary measures include fructose metabolites in blood, breath, feces, and urine, as well as imaging and bioreactor analyses. The total study duration for participants is approximately one month.
CONDITIONS
Brief Title
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or postmenopausal female
- Increased waist circumference (greater than 102 cm for men, greater than 88 cm for women)
- Insulin resistance with HOMA score greater than 2.5
- Age between 18 and 70 years
You will not qualify if you...
- Use of systemic medication (except paracetamol), antibiotics, or pro-/prebiotics in the past three months or during the study
- History of a cardiovascular event
- History of cholecystectomy
- Untreated gastrointestinal diseases or abnormal bowel habits
- Liver enzymes more than 2.5 times the upper limit of normal
- Smoking
- Alcohol abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants take either oral D. piger or placebo once daily for 30 days.
Weekly visits for safety monitoring
Duration - 2 days around baseline and end of treatment
At baseline and after 30 days, participants undergo a fructose challenge test with fomepizole, gastroduodenoscopy, MRI liver, and FibroScan to assess effects of the treatment.
2 visits (in-person) at baseline and after 30 days
Trial Site Locations
Total: 1 location
1
Amsterdam UMC location AMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
M
M Nieuwdorp, prof dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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