Study Evaluating the Safety and Tolerability of a Probioitc

Exclusion Criteria

• •1. History of or ongoing clinically significant disease that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• •2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP.
• •3. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
• •4. Any planned major surgery within the duration of the study.
• •5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibodies or HIV.
• •6. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to Lactobacillus probiotic treatment.
• •7. History of, or ongoing GI disorder, including but not limited to irritable bowel syndrome (IBS), constipation, loose stools or excess gas which, in the discretion of the Investigator, may influence the results or the subject's ability to participate in the study.
• •8. Regular use of any prescribed or non-prescribed medication including antacids and analgesics within 2 weeks prior to the first administration of IP, at the discretion of the Investigator.
• •9. Any use of antibiotics (except local treatment, e.g., eye drops) within 2 weeks prior to the first administration of IP.
• •10. Regular use of supplements, i.e., tablets, drops, capsules etc, that contain L. reuteri or any other probiotics within 2 weeks prior to the first administration of IP.
• •11. Regular intake of foods or beverages that contain L. reuteri or any other probiotics, e.g., yoghurt and other probiotic dairy products, within 2 weeks prior to the first administration of IP. Foods that contain microorganisms, live or dead, that do not confer any health benefit on the host, e.g., regular yoghurt, are allowed.
• •12. Planned treatment or treatment with an investigational drug within 3 months prior to Day 1. Subjects consented and screened but not dosed in previous clinical studies are not excluded.
• •13. Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before the screening visit.
• •14. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IP. Drugs of abuse and alcohol will also be screened during the study (refer to Section 9.6.1).
• •15. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
• •16. Presence or history of drug abuse, as judged by the Investigator.
• •17. History of, or current use of, anabolic steroids, as judged by the Investigator.
• •18. Excessive caffeine consumption defined by a daily intake of \> 5 cups of caffeine-containing beverages.
• •19. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.
• •20. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.