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Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults

NCT06614166 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-27

No results posted yet for this study

Summary

This study is a randomized, open-label, trial in healthy volunteers. Trial participants will be given a medical food product (combination of probiotics and prebiotics) called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration.

Conditions

  • Product Persistence in GI Tract
  • Kinetics
  • Rheumatoid Arthritis (RA)
  • Bone Density

Interventions

OTHER

SBD111 Probiotic Medical Food

Medical food comprised of probiotics and prebiotic fibers

OTHER

SBD121 Probiotic Medical Food

Probiotic medical food comprised of three lactic acid bacteria and one bacillus

Sponsors & Collaborators

  • Solarea Bio, Inc

    lead INDUSTRY

Principal Investigators

  • Alicia E Ballok, PhD · Solarea Bio, Inc

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-14
Primary Completion
2025-05-23
Completion
2025-06-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06614166 on ClinicalTrials.gov