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Effect of F. Prausnitzii on Glycemic Control

Primary Purpose

Pre Diabetes, Impaired Glucose Tolerance, Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
F. prausnitzii and D. piger
Placebo
Sponsored by
MetaboGen AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre Diabetes focused on measuring Faecalibacterium prausnitzii, Desulfovibrio piger

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Written informed consent to participate in the study
  • Man or woman 50-75 years of age
  • Impaired glucose tolerance (IGT; capillary b-glucose 8.9-12.1 mmol/L, 120 minutes after OGTT), impaired fasting glucose (IFG; capillary b-glucose 6.1-6.9 mmol/L) or combined glucose intolerance (CGI, i.e. IFG and IGT)
  • Weight stable ±5 kg for the last 3 months, BMI >18 kg/m2
  • Willingness and possibility to come to the planned study visits, use the Diary and eQuestionnaires as well as follow the study instructions
  • Understand Swedish in speech and writing

Exclusion Criteria:

  • Other reasons for liver inflammation e.g. hepatitis A, hepatitis B, hepatitis C, HIV-positive, confirmed or suspected cirrhosis, Wilsons disease, autoimmune hepatitis, hemochromatosis, alcohol related fatty liver or pancreatitis, laboratory screen AST/ALT >2 (ULN), Bilirubin >1 (ULN)
  • Heart failure NYHA class III, cardiovascular event within 6 months, unstable angina pectoris
  • Diabetes mellitus, HbA1c >47 mmol/mol or fp-Glucose >6.9 mmol/L on 2 occasions
  • Chronic obstructive pulmonary disease and asthma treated with intermittent steroids to be under control
  • Blood pressure >170/105 mmHg
  • Blood donation >500 mL blood <3 months before screening
  • Anemia, Hb <117 g/L females and Hb <134 g/L males; leukopenia, LPK <3.5x1E9/L, ongoing infection CRP >10 mg/L
  • Hyperthyroidism, T4 >22 nmol/L or hypothyroidism, TSH >4,2 mIU/L
  • Laboratory result of clinical significance meaning that participation in the study is unsuitable according to Investigator
  • Calculated glomerular filtration rate (GFR) <60 mL/min/1.73 m2
  • Cancer <5 years since diagnosis, except for basal-cell carcinoma
  • Treatment during the last 3 months with oral steroids, biological drugs, immunosuppressive drugs, e.g. cyklosporin, drugs known to cause liver damage or to be liver toxic
  • Bariatric surgery
  • Antibiotic treatment during the last 3 months or reoccurring antibiotic treatment >3 times a year
  • Regular or sporadic use of probiotic product (not food containing probiotics) during the last 3 months
  • Confirmed IBD, irritable bowel syndrome (IBS), bile acid malabsorption, gastrointestinal infections during the last 3 months or any experienced problems from the gastrointestinal tract during the last month that the Investigator expect could influence the participation in the study
  • Allergy to metronidazol, the adhesive glue for the CGM sensor, milk protein
  • Smoking >10 cigarettes/day
  • Alcohol consumption, >7 units/week females, >14 units/week males
  • Use of narcotics e.g. cannabis, amphetamine (not medical use), hallucinogens, gamma-hydroxybutyric acid
  • Pregnancy, breast-feeding or planned pregnancy
  • Participation in other studies except IGT2

Sites / Locations

  • Wallenberg Laboratory, University of GothenburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

F. prausnitzii and D. piger

Placebo

Arm Description

1 capsule administered once daily 45 minutes before breakfast for 12 weeks

1 capsule administered once daily 45 minutes before breakfast for 12 weeks

Outcomes

Primary Outcome Measures

Glycemic control
Change in time (%) glucose concentration range of 3.5-6.0 mmol/L measured with continuous glucose monitoring (CGM)

Secondary Outcome Measures

Fasting plasma glucose levels
Change in fp-glucose
Hemoglobin A1c
Change in b-HbA1c
Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR)
Change in HOMA-IR
Continuous glucose monitoring (CGM) mean
Change in CGM mean
CGM SD
Change in CGM SD
CGM CV
Change in CGM CV
CGM MAGE
Change in CGM MAGE
Glucose levels
Change in CGM time (%) glucose concentration ≥7.0 mmol/L
Liver fat content
Change in liver fat measured by transient elastography and given as CAP (continous attenuation parameter) in db/m
Liver fat content
Change in liver fat measured by ultrasound (kPa)
Liver fat function test AST
Change in AST
Liver fat function test ALT
Change in ALT
Liver fat function test GGT
Change in GGT

Full Information

First Posted
June 17, 2021
Last Updated
September 1, 2021
Sponsor
MetaboGen AB
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04938843
Brief Title
Effect of F. Prausnitzii on Glycemic Control
Official Title
Effect of F. Prausnitzii on Glycemic Control - a Randomized, Double Blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MetaboGen AB
Collaborators
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The microbiota is associated with a wide spectrum of diseases including diabetes and non-alcoholic fatty liver disease. In this study we will investigate if the bacteria F. prausnitzii, which is a part of the human gut microbiota, can improve metabolic parameters in subjects with impaired glucose control.
Detailed Description
This is a randomized, double blind, placebo-controlled study. Subjects with impaired glucose control will after signing the informed consent and fulfilling the study criteria be randomized to study product or placebo. The randomization ratio between the study product (F. prausnitzii 1E8-5x1E8 CFU and D. piger) and placebo is 1:1. In total 176 subjects will be randomized in the study. The study will start with a Run-in period i.e. all the subjects will be given placebo capsules. The subjects fulfilling the inclusion and exclusion criteria will be randomized at Visit 2 to either study product or placebo in the ration 1:1. The treatment will last for 12 weeks, from Visit 2 to Visit 6. The study is ended with a 2-week period of follow up after the final dose. Blood samples are taken at Visits 1-4 and Visits 6-7. Feces samples are collected at Visit 2-7. One additional fecal sample will be sent by mail approximately one week after Visit 1. Glucose monitoring (CGM) will be initiated at Visit 1 and Visit 5 and followed for 10 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Impaired Glucose Tolerance, Non-Alcoholic Fatty Liver Disease
Keywords
Faecalibacterium prausnitzii, Desulfovibrio piger

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F. prausnitzii and D. piger
Arm Type
Experimental
Arm Description
1 capsule administered once daily 45 minutes before breakfast for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 capsule administered once daily 45 minutes before breakfast for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
F. prausnitzii and D. piger
Intervention Description
Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
Primary Outcome Measure Information:
Title
Glycemic control
Description
Change in time (%) glucose concentration range of 3.5-6.0 mmol/L measured with continuous glucose monitoring (CGM)
Time Frame
From baseline to week 12
Secondary Outcome Measure Information:
Title
Fasting plasma glucose levels
Description
Change in fp-glucose
Time Frame
From baseline to week 12
Title
Hemoglobin A1c
Description
Change in b-HbA1c
Time Frame
From baseline to week 12
Title
Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR)
Description
Change in HOMA-IR
Time Frame
From baseline to week 12
Title
Continuous glucose monitoring (CGM) mean
Description
Change in CGM mean
Time Frame
From baseline to week 12
Title
CGM SD
Description
Change in CGM SD
Time Frame
From baseline to week 12
Title
CGM CV
Description
Change in CGM CV
Time Frame
From baseline to week 12
Title
CGM MAGE
Description
Change in CGM MAGE
Time Frame
From baseline to week 12
Title
Glucose levels
Description
Change in CGM time (%) glucose concentration ≥7.0 mmol/L
Time Frame
From baseline to week 12
Title
Liver fat content
Description
Change in liver fat measured by transient elastography and given as CAP (continous attenuation parameter) in db/m
Time Frame
From baseline to week 12
Title
Liver fat content
Description
Change in liver fat measured by ultrasound (kPa)
Time Frame
From baseline to week 12
Title
Liver fat function test AST
Description
Change in AST
Time Frame
From baseline to week 12
Title
Liver fat function test ALT
Description
Change in ALT
Time Frame
From baseline to week 12
Title
Liver fat function test GGT
Description
Change in GGT
Time Frame
From baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent to participate in the study Man or woman 50-75 years of age Impaired glucose tolerance (IGT; capillary b-glucose 8.9-12.1 mmol/L, 120 minutes after OGTT), impaired fasting glucose (IFG; capillary b-glucose 6.1-6.9 mmol/L) or combined glucose intolerance (CGI, i.e. IFG and IGT) Weight stable ±5 kg for the last 3 months, BMI >18 kg/m2 Willingness and possibility to come to the planned study visits, use the Diary and eQuestionnaires as well as follow the study instructions Understand Swedish in speech and writing Exclusion Criteria: Other reasons for liver inflammation e.g. hepatitis A, hepatitis B, hepatitis C, HIV-positive, confirmed or suspected cirrhosis, Wilsons disease, autoimmune hepatitis, hemochromatosis, alcohol related fatty liver or pancreatitis, laboratory screen AST/ALT >2 (ULN), Bilirubin >1 (ULN) Heart failure NYHA class III, cardiovascular event within 6 months, unstable angina pectoris Diabetes mellitus, HbA1c >47 mmol/mol or fp-Glucose >6.9 mmol/L on 2 occasions Chronic obstructive pulmonary disease and asthma treated with intermittent steroids to be under control Blood pressure >170/105 mmHg Blood donation >500 mL blood <3 months before screening Anemia, Hb <117 g/L females and Hb <134 g/L males; leukopenia, LPK <3.5x1E9/L, ongoing infection CRP >10 mg/L Hyperthyroidism, T4 >22 nmol/L or hypothyroidism, TSH >4,2 mIU/L Laboratory result of clinical significance meaning that participation in the study is unsuitable according to Investigator Calculated glomerular filtration rate (GFR) <60 mL/min/1.73 m2 Cancer <5 years since diagnosis, except for basal-cell carcinoma Treatment during the last 3 months with oral steroids, biological drugs, immunosuppressive drugs, e.g. cyklosporin, drugs known to cause liver damage or to be liver toxic Bariatric surgery Antibiotic treatment during the last 3 months or reoccurring antibiotic treatment >3 times a year Regular or sporadic use of probiotic product (not food containing probiotics) during the last 3 months Confirmed IBD, irritable bowel syndrome (IBS), bile acid malabsorption, gastrointestinal infections during the last 3 months or any experienced problems from the gastrointestinal tract during the last month that the Investigator expect could influence the participation in the study Allergy to metronidazol, the adhesive glue for the CGM sensor, milk protein Smoking >10 cigarettes/day Alcohol consumption, >7 units/week females, >14 units/week males Use of narcotics e.g. cannabis, amphetamine (not medical use), hallucinogens, gamma-hydroxybutyric acid Pregnancy, breast-feeding or planned pregnancy Participation in other studies except IGT2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Maclus, PhD
Phone
+46 705823222
Email
sara.malcus@metabogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanns-Ulrich Marschall
Organizational Affiliation
Wallenberg Laborotory, University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wallenberg Laboratory, University of Gothenburg
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
413 50
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanns-Ulrich Marschall, MD, Prof

12. IPD Sharing Statement

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Effect of F. Prausnitzii on Glycemic Control

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