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Status unknownNCT04938843Updated Sep 2, 2021

Effect of F. Prausnitzii on Glycemic Control

An interventional study of F. prausnitzii and D. piger and Placebo in Pre Diabetes, Impaired Glucose Tolerance and Non-Alcoholic Fatty Liver Disease, sponsored by MetaboGen AB. Status unknown at 1 site in Sweden. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-02.

Sponsored by MetaboGen AB · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Faecalibacterium prausnitzii
  • Desulfovibrio piger
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 176 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

MetaboGen AB is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
176 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementF. prausnitzii and D. piger

    Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks

  • Dietary supplementPlacebo

    Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks

06

What researchers measure

Primary outcomes

  1. Glycemic control

    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 outcomes

  1. Fasting plasma glucose levels

    Change in fp-glucose

    Time frame: From baseline to week 12

  2. Hemoglobin A1c

    Change in b-HbA1c

    Time frame: From baseline to week 12

  3. Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR)

    Change in HOMA-IR

    Time frame: From baseline to week 12

  4. Continuous glucose monitoring (CGM) mean

    Change in CGM mean

    Time frame: From baseline to week 12

  5. CGM SD

    Change in CGM SD

    Time frame: From baseline to week 12

  6. CGM CV

    Change in CGM CV

    Time frame: From baseline to week 12

  7. CGM MAGE

    Change in CGM MAGE

    Time frame: From baseline to week 12

  8. Glucose levels

    Change in CGM time (%) glucose concentration ≥7.0 mmol/L

    Time frame: From baseline to week 12

  9. Liver fat content

    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

  10. Liver fat content

    Change in liver fat measured by ultrasound (kPa)

    Time frame: From baseline to week 12

  11. Liver fat function test AST

    Change in AST

    Time frame: From baseline to week 12

  12. Liver fat function test ALT

    Change in ALT

    Time frame: From baseline to week 12

  13. Liver fat function test GGT

    Change in GGT

    Time frame: From baseline to week 12

07

Study locations

1 of 1 sites recruiting
  • Wallenberg Laboratory, University of Gothenburg
    Gothenburg, Västra Götaland 413 50, Sweden
    • Hanns-Ulrich Marschall, MD, Prof · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04938843
Lead sponsor
MetaboGen AB
Collaborators
Göteborg University
Responsible party
Sponsor
First posted
Jun 24, 2021
Start date
Aug 16, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Sep 2, 2021

Study contacts

Sara Maclus, PhD
Contact
sara.malcus@metabogen.com
+46 705823222
Hanns-Ulrich Marschall
principal investigator · Wallenberg Laborotory, University of Gothenburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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