Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)

NCT06502834 | Recruiting Phase 1 DMC

• 1 other identifier: 2023.0787
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Metabolic Syndrome; Steatosis of Liver

Outcome Measures

Primary Outcomes (11)

• Gut engraftment

  the number of reads of d piger in feces using q pcr

  30 days

• adverse events

  the number of adverse events in both groups

  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

  30 days

• Occurence of anemia

  Number of patients with Hb \< 8,5 mmol/L

  30 days

• Changes in leucocytes

  Number of patients with leucocytes \<4,0 or \>10,5 x10E9 cells/L

  30 days

• Changes in thrombocytes

  Number of patients with thrombocytes \<150 x 10E9 cells/

  30 days

• Changes in aspartate aminotransferase (AST)

  Number of patients with AST \> 43 IU/L

  30 days

• Changes in alanine aminotransferase (ALT)

  Number of patients with ALT \> 45 IU/L

  30 days

• Changes in alkaline phosphatase (ALP)

  Number of patients with ALP \> 126 IU/L

  30 days

• Changes in Gamma-glutamyltransferase (GGT)

  Number of patients with GGT \> 117 IU/L

  30 days

• Changes in total bilirubin

  Number of patients with total bilirubin \> 24 micromol/L

  30 days

Secondary Outcomes (13)

• Fructose in peripheral blood

  30 days

• Fructose metabolites in breath

  30 days

• Time-in-range

  30 days

• Continuous glucose monitoring

  30 days

• Glycemic control

  30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo vial (10ml of glycerol 10% and 10% maltrodextrin)

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).

Dietary Supplement: D piger

Interventions

D piger DIETARY_SUPPLEMENT

Probiotic d piger

D piger

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or (postmenopausal) females
• Increased waist circumference (\>102 cm men, 88\>cm women)
• Insulin resistance (HOMA\>2.5)
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• Max Nieuwdorp: lead

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Fatty Liver

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Max Nieuwdorp, prof dr

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M Nieuwdorp, prof dr

CONTACT

020-5669111; m.nieuwdorp@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The pharmacist will provide the study intervention to the investigator in a coded fashion. Both the investigator and the participant are blinded. In case of emergency, an unblinding protocol is activated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2x10 participants will be randomly allocated to placebo or d piger suspension once daily.

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: July 16, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)