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NCT06614166 · ClinicalTrials.gov registry record · NA
Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults
A NA study of Rheumatoid Arthritis (RA) and Bone Density, sponsored by Solarea Bio.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06614166: Active NA study of Rheumatoid Arthritis (RA) and Bone Density, sponsored by Solarea Bio.
NCT06614166 is a NA study of Rheumatoid Arthritis (RA) and Bone Density that is active but no longer recruiting, run by Solarea Bio. The registered enrollment target is 40 participants, below the 266-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06614166, a NA study of Rheumatoid Arthritis (RA) and Bone Density, is active but no longer recruiting, sponsored by Solarea Bio.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
DNA isolated from fecal swabs will be used to determine the persistence of SBD111 and SBD121 microbes in stool samples up to 28 days following twice-daily oral administration of SBD111 or SBD121 to healthy adults.
Conditions Studied
Interventions
- OTHER SBD111 Probiotic Medical Food
- OTHER SBD121 Probiotic Medical Food
Study Locations (1)
Massachusetts
- Solarea Bio Inc - Waltham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-06-14 |
| Est. Completion | 2025-06-28 |
| Phase | NA |
What the registry record for NCT06614166 still lists
NCT06614166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 266-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Rheumatoid Arthritis (RA) appearing as the primary indexed condition, and to 2 interventions - of which SBD111 Probiotic Medical Food is the first listed.
NCT06614166 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06614166 about?
NCT06614166 is a clinical study titled "Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults". 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 followi...
What is the current status of trial NCT06614166?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-06-14. Estimated completion is 2025-06-28.
What conditions does trial NCT06614166 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis (RA), Bone Density, Product Persistence in GI Tract, Kinetics.
What interventions are being tested in trial NCT06614166?
The interventions under investigation include: SBD111 Probiotic Medical Food (OTHER), SBD121 Probiotic Medical Food (OTHER).
Who is sponsoring clinical trial NCT06614166?
This trial is sponsored by Solarea Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06614166 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06614166's enrollment target sits among peer trials
40 16th of 17 higher than 1 of 17 other Rheumatoid Arthritis (RA) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis (RA) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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