Randomisierte placebokontrollierte Doppelblindstudie zur Überprüfung immunmodulierender Effekte eines Thymushydrolysates bei gesunden Probanden

Double-Blind, Placebo-Controlled, Randomized Trial to Investigate Imnmnomodulating Effects of a Thymic Peptide Mixture in Healthy Volunteers Objective: To investigate immunomodulatory effects and safety aspects of a thymic peptide mixture. Design: Randomized double-blind placebo-controlled trial. Subjects: 24 healthy male volunteers. Intervention: Intramuscular injection of a thymic peptide mixture or placebo on 4 consecutive days. Out come Measures: Primary outcome measures were the number of leukocytes, lymphocytes and the CD4+/CD8+ ratio. A number of further immunological parameters (including lymphocyte subpopulations and phagocytosis of polymorphonuclear neutrophil granulocytes) as well as safety parameters were monitored. Results: Parameters varied over time (mainly according to the time of the day) but there were no relevant differences between groups. No side effects were reported. Conclusion: This study could not show immunomodulatory effects of a thymic peptide mixture in healthy volunteers.