Pre DiabetesNCT04529473
Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Glycaemic Control
A study testing Eubacterium hallii in people with Pre Diabetes and Impaired Glucose Tolerance, run by Atlantia Food Clinical Trials at 3 sites in 3 countries.
Trial summary
This 12 week placebo-controlled study evaluates the efficacy and safety of E. hallii supplementation. Read more about this study
- Who is it for?
- Ages 21 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes, Impaired Glucose Tolerance, Insulin Sensitivity
- What is being tested?
- Eubacterium hallii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 Feb 2021to 23 Aug 2022
- 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 21 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Give written informed consent;
- Be male and aged between 21 and 69 years, inclusive; or be female and aged between 45 and 69, inclusive
- Have a body mass index between 18.5 to 43 Kg/m2;
- Have a waist-circumference > 94cm (37inches) for males and ≥80cm (31.5inches) for females (IDF criterion for Metabolic Syndrome);
- Have a measured Hb1Ac level of 5.5 to 8.0% (36.6 to 63.9 mmol/mol, 6.2 to 10 mmol/L) inclusive;
- If participant has a prior diagnosis of pre-diabetes or Type II diabetes who has been unmedicated for 3-months prior to screening;
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- Be female and be post or peri-menopausal (female who have not had a menstrual period within the previous 9 months)
- Be willing to maintain dietary habits and physical activity levels throughout the study period;
- Be willing to consume the investigational product daily for the duration of the study;
- Capable and willing to wear the PCGM sensor
- Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator
Who cannot join
- Morbid obesity (BMI ≥43.1);
- Prior diagnosis of Type I diabetes mellitus (i.e. a clinical diagnosis made before the screening visit of this study);
- Participants with a prior diagnosis of Type II diabetes who have received a glucose lowering medication (e.g. Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors) or insulin therapy, in the previous 3 months;
- Presence of significant dyslipidaemia (Note: ongoing treatment with stable (3-months) low-dose statins is acceptable);
- Presence of significant cardiovascular disease, including but not limited to significant systemic hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg), pulmonary hypertension, or other unstable cardiopulmonary conditions, limiting or unstable angina, congestive heart failure. (Note: ongoing treatment with stable (3 months) antihypertensives is acceptable);
- Present or recent (within 2 months of screening) use of dietary supplements intended to affect the level of blood glucose. The use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet is allowed, if stable (3-months);
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- Participant regularly takes probiotic supplements, or has done within the 4-weeks prior to screening or plans to during the study;
- Participant has taken oral antibiotics, antifungal, antiparasitic, or antiviral treatment in the 4-weeks prior to screening (topical permissible);
- Participant has a history of co-existing gastrointestinal, and/or gynaecological, and/or urologic pathology (e.g. colon cancer, colitis, Crohn's Disease, Celiac, Endometriosis, prostate cancer);
- Presence or history of significant and diagnosed gastrointestinal diseases that, in the opinion of the investigator, could be associated with disturbed gastrointestinal absorption (e.g., resections, diverticula, active and diagnostically confirmed irritable bowel syndrome, malabsorption syndrome);
- Presence or history of significant other acute or chronic coexisting illness which, in the opinion of the investigator, could compound the outcome of the study, including but not limited to kidney, liver or renal disease/dysfunction, uncontrolled metabolic disease, atrial fibrillation, syncope and known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts;
- Participant has a cardiac pacemaker;
- Present or recent (within 3-months of screening) use of any other medication which, in the opinion of the investigator, could interfere with the outcome of the study, including but not limited to antithrombotic agents, anti-inflammatory agents and chronic NSAID use (except low-dose prophylactic, proton pump inhibitors (PPIs), antihistamines, if ongoing (3-months) and on a stable dose throughout study period);
- Steroids (over-the-counter (OTC) NSAIDS, topical steroids and inhalers are allowed)
- Current or planned participation in a weight-loss regimen, including extreme dietary practices or exercise;
- Having lost >5% of their body weight within 3-months prior to screening;
- Participant has a history of drug and/or alcohol abuse at the time of enrolment;
- Participation in a clinical trial with an investigational product within 60 days before screening, or plans to participate in another study during the study period;
- Participant has a history of non-compliance with medical treatments
- Female subjects with a premature onset of menopause ( those aged less than 45 years at onset) or those whose menopause has been brought on early either by intended or unintended pharmacological intervention (resulting from the treatment of other conditions)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Atlantia Food Clinical Trials, Chicago
Chicago, Illinois, 60611
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Markers of Glycaemic Control in Healthy Hyperglycaemic Adults
This 12 week placebo-controlled study evaluates the efficacy and safety of E. hallii supplementation.
Read the detailed description
There is an increased awareness that the bacteria which forms our microbiome, plays a crucial role in human health and diseases. Numerous studies have highlighted the therapeutic potential of specific bacteria in preventing and treating metabolic, gastrointestinal and other diseases.
The aim of the study is evaluate the effect of administration of a next generation probiotic, Eubacterium hallii, versus placebo on insulin sensitivity and glycemic control, in volunteers with some markers of metabolic syndrome.
Participants will receive their randomized study product daily for 12 weeks. The target population will be otherwise healthy hyperglycaemic adults.
- Conditions
- Pre Diabetes, Impaired Glucose Tolerance, Insulin Sensitivity, Insulin Resistance, Glucose Metabolism Disorders, Metabolic Syndrome
- Being tested
- Eubacterium hallii, Placebo
- Medical subject headings
- Glucose Intolerance, Insulin Resistance, Glucose Metabolism Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eubacterium halliiDietary supplement
Eubacterium hallii, ≥ 1x10^9 live bacterial cells (per capsule)
PlaceboOther
Placebo capsules are identical to the active treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 capsule per day, consumed orally, before breakfast for the duration of the study. Receives: Other: Placebo |
| Eubacterium hallii | Experimental | 1 capsule per day, consumed orally, before breakfast for the duration of the study. Receives: Dietary Supplement: Eubacterium hallii |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour blood glucose incremental Area Under the Curve (AUC)
as measured by standard Oral Glucose Tolerance Test (OGTT)
Measured: From Baseline to Week 12
2-hour blood insulin incremental AUC
as measured by standard OGTT
Measured: From Baseline to Week 12
Post-prandial insulin sensitivity
as measured by insulin sensitivity index-OGTT (ISI-OGTT)
Measured: From Baseline to Week 12
Glycated haemoglobin (HbA1c)
Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels
Measured: From Baseline to Week 12
Secondary outcomes (5)
Glycaemic Variability (GV) over the 24-hr period
as measured by the Professional Continuous Glucose Monitoring (PCGM) device over 10as measured by the PCGM device over 10-14 days at the start and end of intervention
Measured: From Baseline to Week 12
Glycaemic Control (GC) over the 24-hr period
as measured by the PCGM device over 10-14 days at the start and end of intervention
Measured: From Baseline to Week 12
GV during sleeping hours
as measured by the PCGM device over 10-14 days at the start and end of intervention
Measured: From Baseline to Week 12
Fasting Blood Glucose
Change from baseline to Week 12 in each of the treatment groups as compared to placebo in fasting blood glucose levels
Measured: From Baseline to Week 12
Blood Pressure
Change from baseline to Week 12 in Systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)
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 posted27 Aug 2020
- Study start3 Feb 2021
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantia Food Clinical Trials
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Caelus Pharmaceuticals BV
- Responsible party
- Sponsor
- Investigators
- James Ryan, MD, Principal investigator, Atlantia Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529473
- Sponsor's protocol ID
- AFCRO-115
- Status last verified
- Nov 2022
- First submitted
- 18 Aug 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Attaye I, Bird JK, Nieuwdorp M, Gul S, Seegers JFML, Morrison S, Hofkens S, Herrema H, Bui N, Puhlmann ML, de Vos WM. Anaerobutyricum soehngenii improves glycemic control and other markers of cardio-metabolic health in adults at risk of type 2 diabetes. Gut Microbes. 2025 Dec;17(1):2504115. doi: 10.1080/19490976.2025.2504115. Epub 2025 May 15.
PubMed 40371708
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Markers of Glycaemic Control in Healthy Hyperglycaemic Adults
- ClinicalTrials.gov ID
- NCT04529473
- Acronym / sponsor ID
- AFCRO-115
- Conditions
- Pre Diabetes, Impaired Glucose Tolerance, Insulin Sensitivity, Insulin Resistance, Glucose Metabolism Disorders, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Atlantia Food Clinical TrialsIndustry (pharma, biotech, devices)
- Collaborators
- Caelus Pharmaceuticals BV
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 27 Aug 2020 (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.
This 12 week placebo-controlled study evaluates the efficacy and safety of E. hallii supplementation.
Detailed description
There is an increased awareness that the bacteria which forms our microbiome, plays a crucial role in human health and diseases. Numerous studies have highlighted the therapeutic potential of specific bacteria in preventing and treating metabolic, gastrointestinal and other diseases.
The aim of the study is evaluate the effect of administration of a next generation probiotic, Eubacterium hallii, versus placebo on insulin sensitivity and glycemic control, in volunteers with some markers of metabolic syndrome.
Participants will receive their randomized study product daily for 12 weeks. The target population will be otherwise healthy hyperglycaemic adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo1 capsule per day, consumed orally, before breakfast for the duration of the study. |
| Eubacterium hallii | Experimental | Dietary Supplement: Eubacterium hallii1 capsule per day, consumed orally, before breakfast for the duration of the study. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Give written informed consent;
- Be male and aged between 21 and 69 years, inclusive; or be female and aged between 45 and 69, inclusive
- Have a body mass index between 18.5 to 43 Kg/m2;
- Have a waist-circumference > 94cm (37inches) for males and ≥80cm (31.5inches) for females (IDF criterion for Metabolic Syndrome);
- Have a measured Hb1Ac level of 5.5 to 8.0% (36.6 to 63.9 mmol/mol, 6.2 to 10 mmol/L) inclusive;
Key exclusion criteria (20 listed)
- Morbid obesity (BMI ≥43.1);
- Prior diagnosis of Type I diabetes mellitus (i.e. a clinical diagnosis made before the screening visit of this study);
- Participants with a prior diagnosis of Type II diabetes who have received a glucose lowering medication (e.g. Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors) or insulin therapy, in the previous 3 months;
- Presence of significant dyslipidaemia (Note: ongoing treatment with stable (3-months) low-dose statins is acceptable);
- Presence of significant cardiovascular disease, including but not limited to significant systemic hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg), pulmonary hypertension, or other unstable cardiopulmonary conditions, limiting or unstable angina, congestive heart failure. (Note: ongoing treatment with stable (3 months) antihypertensives is acceptable);
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 |
|---|---|---|
| Eubacterium halliiEubacterium hallii, ≥ 1x10^9 live bacterial cells (per capsule) | Dietary supplement | Eubacterium hallii |
| PlaceboPlacebo capsules are identical to the active treatment | Other | Placebo |
Primary outcome
2-hour blood glucose incremental Area Under the Curve (AUC)
Time frame: From Baseline to Week 12
as measured by standard Oral Glucose Tolerance Test (OGTT)
2-hour blood insulin incremental AUC
Time frame: From Baseline to Week 12
as measured by standard OGTT
Post-prandial insulin sensitivity
Time frame: From Baseline to Week 12
as measured by insulin sensitivity index-OGTT (ISI-OGTT)
Glycated haemoglobin (HbA1c)
Time frame: From Baseline to Week 12
Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels
5 secondary outcomes
Glycaemic Variability (GV) over the 24-hr period
Time frame: From Baseline to Week 12
Glycaemic Control (GC) over the 24-hr period
Time frame: From Baseline to Week 12
GV during sleeping hours
Time frame: From Baseline to Week 12
Fasting Blood Glucose
Time frame: From Baseline to Week 12
Blood Pressure
Time frame: From Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 40371708Attaye I, Bird JK, Nieuwdorp M, Gul S, Seegers JFML, Morrison S, Hofkens S, Herrema H, Bui N, Puhlmann ML, de Vos WM. Anaerobutyricum soehngenii improves glycemic control and other markers of cardio-metabolic health in adults at risk of type 2 diabetes. Gut Microbes. 2025 Dec;17(1):2504115. doi: 10.1080/19490976.2025.2504115. Epub 2025 May 15.
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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.
James Ryan, MD principal investigator
Atlantia Food Clinical Trials
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eubacterium hallii in people with Pre Diabetes and Impaired Glucose Tolerance, run by Atlantia Food Clinical Trials at 3 sites in 3 countries.
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 11 inclusion and 20 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: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Ireland, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-hour blood glucose incremental Area Under the Curve (AUC) (time frame: From Baseline to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529473, which also lists 1 linked publication.
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 15 Nov 2022.