NCT04433208

Dietary Supplement With and Without a Probiotic

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Prolacta Bioscience · Industry
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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. The combination should support general gastrointestinal health. The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-44.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Complex oligosaccharide	Complex oligosaccharide concentrate
DIETARY_SUPPLEMENT	Probiotic	Probiotic
OTHER	PPI	Over-the-counter proton pump inhibitor (PPI)
OTHER	H2 Blocker	Over-the-counter H2 blocker

Timeline

• Start date: 2020-03-13
• Primary completion: 2020-12-02
• Completion: 2020-12-02
• First posted: 2020-06-16
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

1 site across 1 country: United States