Randomized, placebo-controlled clinical study for the evalutation of immune modulation by Immulink MBG (Beta 1-3; 1-6 D-glucan; Poly-(l-6)-ß-D-glucopyranosyl-(l,3)-ß-D-glucopyranose) in healthy adult volunteers

Super Beta Glucan Inc., Biomedical Research Division0 个研究点目标入组 173 人开始时间: 2022年10月31日最近更新: 2023年5月1日

试验速览

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36766186/ (added 20/04/2023)

•1. Male and female (unpregnant) subjects between 18 and 55 years of age, inclusive.
•2. Participants willing to refrain from taking any non-essential medication from the onset of the study until follow up evaluation, with the exception of medical emergency.

•1. Participant who was not able to give adequate informed consent; without the legal ability to act; who lack sufficient understanding or capacity to make or communicate responsible decisions.
•2. Participants who were unable to adhere to the study protocols.
•3. Participants participated in any other research study.
•4. Participants who were current smoker or tobacco related product user.
•5. Women who are pregnant or nursing.
•6. Participants with status asthmaticus.
•7. Participants with uncontrolled hypertension, peripheral vascular disease, hepatic diseases (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.
•8. Participants with evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal gastrointestinal, immunocompromising, or neurological disease, including seizure disorder.
•9. Participants who have had organ transplantation(s), under treatments of immunosuppressant medications, diagnosed with cancer or any other malignancy, or type I/II diabetes mellitus.
•10. Participants who have had any life threatening allergic event in the past.
•11. Participants or have allergy events to dextrose monohydrate.
•12. Participants taking medications, mainly glucocorticoids.

发起方

Super Beta Glucan Inc., Biomedical Research Division