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Effect of F. Prausnitzii on Glycemic Control

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ClinicalTrials.gov Identifier: NCT04938843
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
MetaboGen AB

Tracking Information
First Submitted Date  ICMJE June 17, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE August 16, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
Glycemic control [ Time Frame: From baseline to week 12 ]
Change in time (%) glucose concentration range of 3.5-6.0 mmol/L measured with continuous glucose monitoring (CGM)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
  • Fasting plasma glucose levels [ Time Frame: From baseline to week 12 ]
    Change in fp-glucose
  • Hemoglobin A1c [ Time Frame: From baseline to week 12 ]
    Change in b-HbA1c
  • Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR) [ Time Frame: From baseline to week 12 ]
    Change in HOMA-IR
  • Continuous glucose monitoring (CGM) mean [ Time Frame: From baseline to week 12 ]
    Change in CGM mean
  • CGM SD [ Time Frame: From baseline to week 12 ]
    Change in CGM SD
  • CGM CV [ Time Frame: From baseline to week 12 ]
    Change in CGM CV
  • CGM MAGE [ Time Frame: From baseline to week 12 ]
    Change in CGM MAGE
  • Glucose levels [ Time Frame: From baseline to week 12 ]
    Change in CGM time (%) glucose concentration ≥7.0 mmol/L
  • Liver fat content [ Time Frame: From baseline to week 12 ]
    Change in liver fat measured by transient elastography and given as CAP (continous attenuation parameter) in db/m
  • Liver fat content [ Time Frame: From baseline to week 12 ]
    Change in liver fat measured by ultrasound (kPa)
  • Liver fat function test AST [ Time Frame: From baseline to week 12 ]
    Change in AST
  • Liver fat function test ALT [ Time Frame: From baseline to week 12 ]
    Change in ALT
  • Liver fat function test GGT [ Time Frame: From baseline to week 12 ]
    Change in GGT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of F. Prausnitzii on Glycemic Control
Official Title  ICMJE Effect of F. Prausnitzii on Glycemic Control - a Randomized, Double Blind, Placebo-controlled Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pre Diabetes
  • Impaired Glucose Tolerance
  • Non-Alcoholic Fatty Liver Disease
Intervention  ICMJE
  • Dietary Supplement: F. prausnitzii and D. piger
    Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
  • Dietary Supplement: Placebo
    Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
Study Arms  ICMJE
  • Experimental: F. prausnitzii and D. piger
    1 capsule administered once daily 45 minutes before breakfast for 12 weeks
    Intervention: Dietary Supplement: F. prausnitzii and D. piger
  • Placebo Comparator: Placebo
    1 capsule administered once daily 45 minutes before breakfast for 12 weeks
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2021)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sara Maclus, PhD +46 705823222 sara.malcus@metabogen.com
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938843
Other Study ID Numbers  ICMJE META003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MetaboGen AB
Study Sponsor  ICMJE MetaboGen AB
Collaborators  ICMJE Göteborg University
Investigators  ICMJE
Principal Investigator: Hanns-Ulrich Marschall Wallenberg Laborotory, University of Gothenburg
PRS Account MetaboGen AB
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP