ObesityPhase 1PIGERNCT06502834
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
A Phase 1 study testing D piger in people with Obesity and Metabolic Syndrome, run by Max Nieuwdorp at 1 site in Netherlands.
Trial summary
The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight. The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Metabolic Syndrome, Steatosis of Liver
- What is being tested?
- D piger
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2024to 1 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or (postmenopausal) females
- Increased waist circumference (>102 cm men, 88>cm women)
- Insulin resistance (HOMA>2.5)
- 18-70 years
Who cannot join
- Use of systemic medication (except for paracetamol), including 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location AMC
Amsterdam
max nieuwdorp, MD PhD, 0031 20 5669111, m.nieuwdorp@amsterdamumc.nl
About this study
The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.
The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.
Read the detailed description
The investigators perform a randomized, placebo controlled trial in 2x10 participants.
The participants will be given placebo or d piger as an oral suspension once daily for 30 days.
At baseline and after 30 days, a fructose challenge test with fomepizole, gastroduodenoscopy and MRI liver + FibroScan will be performed. Patient will attend the clinical trial unit weekly for safety visits.
The participants will be overweight males or females age 18-70 with impaired glucose tolerance.
- Conditions
- Obesity, Metabolic Syndrome, Steatosis of Liver
- Being tested
- D piger, Placebo
- Medical subject headings
- Obesity, Metabolic Syndrome, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D pigerDietary supplement
Probiotic d piger
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo vial (10ml of glycerol 10% and 10% maltrodextrin) Receives: Dietary Supplement: Placebo |
| D piger | Experimental | D. piger vial with 109 colony forming units (CFU) (=108 CFU D. piger per ml in 10ml of glycerol 10% and 10% maltrodextrin). Receives: Dietary Supplement: D piger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut engraftment
the number of reads of d piger in feces using q pcr
Measured: 30 days
adverse events
the number of adverse events in both groups
Measured: 30 days
Renal function
Number of participants with a decreased kidney function, defined as a rise in serum creatinine of >26,5 micromol/L in 48 h
Measured: 30 days
Occurence of anemia
Number of patients with Hb < 8,5 mmol/L
Measured: 30 days
Changes in leucocytes
Number of patients with leucocytes <4,0 or >10,5 x10E9 cells/L
Measured: 30 days
Changes in thrombocytes
Number of patients with thrombocytes <150 x 10E9 cells/
Measured: 30 days
Changes in aspartate aminotransferase (AST)
Number of patients with AST > 43 IU/L
Measured: 30 days
Changes in alanine aminotransferase (ALT)
Number of patients with ALT > 45 IU/L
Measured: 30 days
Changes in alkaline phosphatase (ALP)
Number of patients with ALP > 126 IU/L
Measured: 30 days
Changes in Gamma-glutamyltransferase (GGT)
Number of patients with GGT > 117 IU/L
Measured: 30 days
Changes in total bilirubin
Number of patients with total bilirubin > 24 micromol/L
Measured: 30 days
Secondary outcomes (13)
Fructose in peripheral blood
Area under the curve of fructose in peripheral blood upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6
Measured: 30 days
Fructose metabolites in breath
Area under the curve of various metabolites (e.g. ethanol) will be measured in breath samples upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6
Measured: 30 days
Time-in-range
Increase in Time-in-range (TIR,%), a parameter of continuous glucose monitoring devices, where TIR can be between 0 and 100%. A higher TIR reflects a better outcome.
Measured: 30 days
Continuous glucose monitoring
Decrease in glucose variability (GV, %), a parameter of continuous glucose monitoring devices, where GV can be between 0 and 100%. A lower GV reflects a better outcome.
Measured: 30 days
Glycemic control
Changes in fasting glucose (mmol/L)
Measured: 30 days
Dietary intake
Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visit 2,3,4,5 and 7
Measured: 30 days
Questionnaires
Changes in Gastro-intestinal Quality of Life Index (GIQLI score) (points). The minimum and maximum score are 31 and 155 points respectively, and a higher score reflects a better outcome.
Measured: 30 days
Intestinal microbiota composition
Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants.
Measured: 30 days
Fructose metabolites in feces
Using 24h feces, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as short chain fatty acids (SCFAs) and bile acids.
Measured: 30 days
Fructose metabolites in urine
Using 24h urine, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as SCFAs and bile acids.
Measured: 30 days
Bioreactor analyses
Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.
Measured: 30 days
MRI
Liver fat measured by proton density fat fraction (PDFF) MRI liver
Measured: 30 days
FibroScan
Liver stiffness measured by FibroScan
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 May 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2x10 participants will be randomly allocated to placebo or d piger suspension once daily.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Nieuwdorp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Max Nieuwdorp, Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)
- Investigators
- Max Nieuwdorp, prof dr, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502834
- Sponsor's protocol ID
- 2023.0787
- Acronym
- PIGER
- Status last verified
- Jul 2024
- First submitted
- 20 May 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
- ClinicalTrials.gov ID
- NCT06502834
- Acronym / sponsor ID
- PIGER / 2023.0787
- Conditions
- Obesity, Metabolic Syndrome, Steatosis of Liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Max NieuwdorpUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.
The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.
Detailed description
The investigators perform a randomized, placebo controlled trial in 2x10 participants.
The participants will be given placebo or d piger as an oral suspension once daily for 30 days.
At baseline and after 30 days, a fructose challenge test with fomepizole, gastroduodenoscopy and MRI liver + FibroScan will be performed. Patient will attend the clinical trial unit weekly for safety visits.
The participants will be overweight males or females age 18-70 with impaired glucose tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2x10 participants will be randomly allocated to placebo or d piger suspension once daily.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo vial (10ml of glycerol 10% and 10% maltrodextrin) |
| D piger | Experimental | Dietary Supplement: D pigerD. piger vial with 109 colony forming units (CFU) (=108 CFU D. piger per ml in 10ml of glycerol 10% and 10% maltrodextrin). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or (postmenopausal) females
- Increased waist circumference (>102 cm men, 88>cm women)
- Insulin resistance (HOMA>2.5)
- 18-70 years
Key exclusion criteria (7 listed)
- Use of systemic medication (except for paracetamol), including 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D pigerProbiotic d piger | Dietary supplement | D piger |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Gut engraftment
Time frame: 30 days
the number of reads of d piger in feces using q pcr
adverse events
Time frame: 30 days
the number of adverse events in both groups
Renal function
Time frame: 30 days
Number of participants with a decreased kidney function, defined as a rise in serum creatinine of >26,5 micromol/L in 48 h
Occurence of anemia
Time frame: 30 days
Number of patients with Hb < 8,5 mmol/L
Changes in leucocytes
Time frame: 30 days
Number of patients with leucocytes <4,0 or >10,5 x10E9 cells/L
Changes in thrombocytes
Time frame: 30 days
Number of patients with thrombocytes <150 x 10E9 cells/
Changes in aspartate aminotransferase (AST)
Time frame: 30 days
Number of patients with AST > 43 IU/L
Changes in alanine aminotransferase (ALT)
Time frame: 30 days
Number of patients with ALT > 45 IU/L
Changes in alkaline phosphatase (ALP)
Time frame: 30 days
Number of patients with ALP > 126 IU/L
Changes in Gamma-glutamyltransferase (GGT)
Time frame: 30 days
Number of patients with GGT > 117 IU/L
Changes in total bilirubin
Time frame: 30 days
Number of patients with total bilirubin > 24 micromol/L
13 secondary outcomes
Fructose in peripheral blood
Time frame: 30 days
Fructose metabolites in breath
Time frame: 30 days
Time-in-range
Time frame: 30 days
Continuous glucose monitoring
Time frame: 30 days
Glycemic control
Time frame: 30 days
Dietary intake
Time frame: 30 days
Questionnaires
Time frame: 30 days
Intestinal microbiota composition
Time frame: 30 days
Fructose metabolites in feces
Time frame: 30 days
Fructose metabolites in urine
Time frame: 30 days
Bioreactor analyses
Time frame: 30 days
MRI
Time frame: 30 days
FibroScan
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Nieuwdorp, prof dr principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D piger in people with Obesity and Metabolic Syndrome, run by Max Nieuwdorp at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M Nieuwdorp, prof dr (020-5669111, m.nieuwdorp@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut engraftment (time frame: 30 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.