Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.
The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers who have received antibiotics. The combination should support general gastrointestinal health. This study is a multi-dose randomized cohort trial using 18 subjects per cohort for a total of 90 healthy adult volunteers ages 18-75.
Study Type
OBSERVATIONAL
Enrollment
92
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Concentrated milk fortifiers from donor human milk
B. infantis
Altasciences
Cypress, California, United States
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.
Time frame: Baseline, Day, 5, 14, 35
Changes in Immune Markers Assessment at Day 5, 14 and 28
Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.
Time frame: Baseline-28 days
Blood Pressures of Subjects From Baseline to Day 35
Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure \[BP\]). Descriptive statistics performed by dose group and visit.
Time frame: Day 0 - 35
Heart Rates of Subjects From Baseline to Day 35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.
Time frame: Day 0-35
Respiratory Rates of Subjects From Baseline to Day 35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.
Time frame: Day 0-35
Temperatures of Subjects From Baseline to Day 35
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)
Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).
Time frame: Day 0-35