Pre DiabetesNCT04938843
Effect of F. Prausnitzii on Glycemic Control
A study testing F. prausnitzii and D. piger in people with Pre Diabetes and Impaired Glucose Tolerance, run by MetaboGen AB at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes, Impaired Glucose Tolerance, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- F. prausnitzii and D. piger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteSweden
- Study dates
- 16 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Wallenberg Laboratory, University of Gothenburg
Gothenburg, Västra Götaland County, 413 50
Hanns-Ulrich Marschall, MD, Prof
About this study
Official title: Effect of F. Prausnitzii on Glycemic Control - a Randomized, Double Blind, Placebo-controlled Study
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.
- Being tested
- F. prausnitzii and D. piger, Placebo
- Keywords
- Faecalibacterium prausnitzii, Desulfovibrio piger
- Medical subject headings
- Glucose Intolerance, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F. prausnitzii and D. pigerDietary supplement
Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
PlaceboDietary supplement
Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| F. prausnitzii and D. piger | Experimental | 1 capsule administered once daily 45 minutes before breakfast for 12 weeks Receives: Dietary Supplement: F. prausnitzii and D. piger |
| Placebo | Placebo comparator | 1 capsule administered once daily 45 minutes before breakfast for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Change in time (%) glucose concentration range of 3.5-6.0 mmol/L measured with continuous glucose monitoring (CGM)
Measured: From baseline to week 12
Secondary outcomes (13)
Fasting plasma glucose levels
Change in fp-glucose
Measured: From baseline to week 12
Hemoglobin A1c
Change in b-HbA1c
Measured: From baseline to week 12
Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR)
Change in HOMA-IR
Measured: From baseline to week 12
Continuous glucose monitoring (CGM) mean
Change in CGM mean
Measured: From baseline to week 12
CGM SD
Change in CGM SD
Measured: From baseline to week 12
CGM CV
Change in CGM CV
Measured: From baseline to week 12
CGM MAGE
Change in CGM MAGE
Measured: From baseline to week 12
Glucose levels
Change in CGM time (%) glucose concentration ≥7.0 mmol/L
Measured: From baseline to week 12
Liver fat content
Change in liver fat measured by transient elastography and given as CAP (continous attenuation parameter) in db/m
Measured: From baseline to week 12
Liver fat content
Change in liver fat measured by ultrasound (kPa)
Measured: From baseline to week 12
Liver fat function test AST
Change in AST
Measured: From baseline to week 12
Liver fat function test ALT
Change in ALT
Measured: From baseline to week 12
Liver fat function test GGT
Change in GGT
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start16 Aug 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetaboGen AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Hanns-Ulrich Marschall, Principal investigator, Wallenberg Laborotory, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938843
- Sponsor's protocol ID
- META003
- Status last verified
- Sep 2021
- First submitted
- 17 Jun 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of F. Prausnitzii on Glycemic Control - a Randomized, Double Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04938843
- Acronym / sponsor ID
- META003
- Keywords
- Faecalibacterium prausnitzii, Desulfovibrio piger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- MetaboGen ABIndustry (pharma, biotech, devices)
- Collaborators
- Göteborg University
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F. prausnitzii and D. piger | Experimental | Dietary Supplement: F. prausnitzii and D. piger1 capsule administered once daily 45 minutes before breakfast for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule administered once daily 45 minutes before breakfast for 12 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F. prausnitzii and D. pigerDietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks | Dietary supplement | F. prausnitzii and D. piger |
| PlaceboDietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks | Dietary supplement | Placebo |
Primary outcome
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)
13 secondary outcomes
Fasting plasma glucose levels
Time frame: From baseline to week 12
Hemoglobin A1c
Time frame: From baseline to week 12
Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR)
Time frame: From baseline to week 12
Continuous glucose monitoring (CGM) mean
Time frame: From baseline to week 12
CGM SD
Time frame: From baseline to week 12
CGM CV
Time frame: From baseline to week 12
CGM MAGE
Time frame: From baseline to week 12
Glucose levels
Time frame: From baseline to week 12
Liver fat content
Time frame: From baseline to week 12
Liver fat content
Time frame: From baseline to week 12
Liver fat function test AST
Time frame: From baseline to week 12
Liver fat function test ALT
Time frame: From baseline to week 12
Liver fat function test GGT
Time frame: From baseline to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
Related trials for Pre Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanns-Ulrich Marschall principal investigator
Wallenberg Laborotory, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F. prausnitzii and D. piger in people with Pre Diabetes and Impaired Glucose Tolerance, run by MetaboGen AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Maclus, PhD (+46 705823222, sara.malcus@metabogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: From baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.