NCT05141903

Dietary Supplement With and Without a Probiotic and/or Antibiotic

Dietary Study of a Complex Oligosaccharide With and Without a Probiotic Following Antibiotic Treatment in Healthy Volunteers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 92 (actual)
• Sponsor: Prolacta Bioscience · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Antibiotic	Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
DIETARY_SUPPLEMENT	HMO Concentrate	Concentrated milk fortifiers from donor human milk
DIETARY_SUPPLEMENT	Probiotic	B. infantis
DIETARY_SUPPLEMENT	Food Supplement	Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)

Timeline

• Start date: 2021-09-21
• Primary completion: 2022-05-23
• Completion: 2022-06-09
• First posted: 2021-12-02
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

1 site across 1 country: United States