Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of F. Prausnitzii on Glycemic Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04938843
Recruitment Status : Not yet recruiting
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
MetaboGen AB

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.

Condition or disease Intervention/treatment Phase
Pre Diabetes Impaired Glucose Tolerance Non-Alcoholic Fatty Liver Disease Dietary Supplement: F. prausnitzii and D. piger Dietary Supplement: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of F. Prausnitzii on Glycemic Control - a Randomized, Double Blind, Placebo-controlled Study
Estimated Study Start Date : August 16, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F. prausnitzii and D. piger
1 capsule administered once daily 45 minutes before breakfast for 12 weeks
Dietary Supplement: F. prausnitzii and D. piger
Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks

Placebo Comparator: Placebo
1 capsule administered once daily 45 minutes before breakfast for 12 weeks
Dietary Supplement: Placebo
Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Fasting plasma glucose levels [ Time Frame: From baseline to week 12 ]
    Change in fp-glucose

  2. Hemoglobin A1c [ Time Frame: From baseline to week 12 ]
    Change in b-HbA1c

  3. Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR) [ Time Frame: From baseline to week 12 ]
    Change in HOMA-IR

  4. Continuous glucose monitoring (CGM) mean [ Time Frame: From baseline to week 12 ]
    Change in CGM mean

  5. CGM SD [ Time Frame: From baseline to week 12 ]
    Change in CGM SD

  6. CGM CV [ Time Frame: From baseline to week 12 ]
    Change in CGM CV

  7. CGM MAGE [ Time Frame: From baseline to week 12 ]
    Change in CGM MAGE

  8. Glucose levels [ Time Frame: From baseline to week 12 ]
    Change in CGM time (%) glucose concentration ≥7.0 mmol/L

  9. 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

  10. Liver fat content [ Time Frame: From baseline to week 12 ]
    Change in liver fat measured by ultrasound (kPa)

  11. Liver fat function test AST [ Time Frame: From baseline to week 12 ]
    Change in AST

  12. Liver fat function test ALT [ Time Frame: From baseline to week 12 ]
    Change in ALT

  13. Liver fat function test GGT [ Time Frame: From baseline to week 12 ]
    Change in GGT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938843


Contacts
Layout table for location contacts
Contact: Sara Maclus, PhD +46 705823222 sara.malcus@metabogen.com

Locations
Layout table for location information
Sweden
Wallenberg Laboratory, University of Gothenburg
Gothenburg, Västra Götaland, Sweden, 413 50
Principal Investigator: Hanns-Ulrich Marschall, MD, Prof         
Sponsors and Collaborators
MetaboGen AB
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Hanns-Ulrich Marschall Wallenberg Laborotory, University of Gothenburg
Layout table for additonal information
Responsible Party: MetaboGen AB
ClinicalTrials.gov Identifier: NCT04938843    
Other Study ID Numbers: META003
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MetaboGen AB:
Faecalibacterium prausnitzii
Desulfovibrio piger
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Prediabetic State
Glucose Intolerance
Digestive System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia