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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Pia
Rasinkangas
-
pia.rasinkangas@iff.com
Mr
Mahadev
Ramjee
+44 (0)1772237822
mahadev.ramjee@panthera-bio.com
Miss
Anna
Aldred
+44 (0)1483 977773
anna.aldred@fgk-cro.com
Safety and efficacy of a potential new probiotic in healthy volunteers
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Probiotics are defined as “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host”. Our gastrointestinal tract and the gut microbiota contain trillions of bacteria, which are important for functions such as digesting food and educating and activating the immune system. Next-generation probiotics (NGPs) are a completely new class of probiotics based on bacterial strains that naturally live in the human body. In this study, a potential NGP Akkermansia strain will be clinically tested for the first time in healthy volunteers.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Having hypersensitivity or history of allergy to the trial product components, or a history of adverse effects, intolerance, or allergic reactions attributed to any medications 2. Suffering from a chronic disease (e.g., autoimmune disease, cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease, terminal illness) or from an illness that may preclude the participant’s ability to complete the trial or that may confound the trial outcomes according to the assessment by the investigator 3. History of heart failure with reduced left ventricular ejection fraction (LVEF) defined as any past measurement of LVEF ≤ 40%4. Unstable heart failure with preserved ejection fraction, defined as: a) New York Heart Association (NYHA) class III-IV or, b) Hospitalisation or emergency room visit for heart failure during the past one year or, c) Need for intravenous diuretics in the outpatient setting within 6 months of Screening or, d) Concomitant treatment with a high dose of diuretics (i.e., furosemide 80 mg/day or equivalent) 5. Abnormal laboratory values at screening, including any of the following: 5.1. AST or ALT ≥ 5 × ULN (upper limit of normal) 5.2. Alkaline phosphatase > 2 × ULN 5.3. Impaired renal function defined as eGFR ≤ 60 mL/minute/1.73 m2 at screening (estimated according to the CKD Epidemiology collaboration) (Inker et al 2021) 5.4. Albumin < 3.5 g/dL (35 g/L) 5.5. INR ≥ 1.3 L 5.6. Any other clinically significant abnormalities in serum chemistry, hematology, or urinalysis results as judged by the investigator6. Uncontrolled hypertension at screening and randomization, defined as mean systolic blood pressure >160 mm Hg or mean diastolic blood pressure >100 mm Hg (based on the average of 3 blood pressure readings if the first reading is outside of these limits).7. History of diagnosed gastrointestinal complications at screening or randomization. (e.g., Crohn’s disease, ulcer, IBS-mixed, IBS-constipation, IBS-diarrhea, celiac disease) 8. Prior abdominal surgery (e.g., gastric bypass, gastrectomy, gastric band, visceral surgery) at screening or randomization that, in the opinion of the investigator, may present a risk for the participant or confound trial results.9. Clinically significant diagnosis of any eating disorder at screening or randomisation (e.g., anorexia, bulimia) that may impact the safety of the subject or the trial data as per investigator judgement. 10. Antibiotic course within 3 months before screening or any active infection during the screening period or ongoing chronic infection for the duration of the study. 11. Having a lifestyle deemed incompatible with the trial according to the investigator, e.g., a specific extreme diet (e.g., hypocaloric, ketogenic), intense physical activity > 10 hours/week. 12. Any self-declared clinically significant alcohol misuse (more than 14 units of alcohol per week) at screening or randomisation that may impact the safety of the subject or the trial data.13. Self-declared use of illicit drugs at screening or randomisation that may impact the safety of the subject or the trial data as per investigator judgement.14. Pregnant or lactating female, or pregnancy planned during the trial 15. The investigator believes that the individual may be uncooperative and/or noncompliant and should therefore not participate in the trial 16. Presenting a psychological or linguistic incapacity to understand and sign the informed consent 17. Participating in another clinical trial or in an exclusion period
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Pia
Rasinkangas
-
pia.rasinkangas@iff.com
Miss
Anna
Aldred
+44 (0)1483 977773
anna.aldred@fgk-cro.com
Mr
Mahadev
Ramjee
+44 (0)1772237822
mahadev.ramjee@panthera-bio.com
The study is sponsored by Danisco Sweeteners Oy and funded by Danisco Sweeteners Oy.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
