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NCT05141903 · ClinicalTrials.gov registry record
Dietary Supplement With and Without a Probiotic and/or Antibiotic
A clinical trial of Healthy Adults, sponsored by Prolacta Bioscience.
- Completed
- Registry status
- 92
- Enrollment target
- 1
- Study location
NCT05141903: Completed study of Healthy Adults, sponsored by Prolacta Bioscience.
NCT05141903 is a study of Healthy Adults that has completed, run by Prolacta Bioscience. The registered enrollment target is 92 participants, above the 84-participant average among 33 other Healthy Adults trials with a reported enrollment target (10% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05141903, a study of Healthy Adults, has completed, sponsored by Prolacta Bioscience.
- COMPLETED
- Registry status
- 92 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Probiotic
- DIETARY_SUPPLEMENT Antibiotic
- DIETARY_SUPPLEMENT HMO Concentrate
- DIETARY_SUPPLEMENT Food Supplement
Study Locations (1)
California
- Altasciences - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2022-06-09 |
What the finished NCT05141903 record still lists
NCT05141903 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 84-participant average among 33 other Healthy Adults trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Healthy Adults appearing as the primary indexed condition, and to 4 interventions - of which Probiotic is the first listed.
NCT05141903 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05141903 about?
NCT05141903 is a clinical study titled "Dietary Supplement With and Without a Probiotic and/or Antibiotic". 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.
What is the current status of trial NCT05141903?
This trial is currently completed. The enrollment target is 92 participants. The study started on 2021-09-21. Estimated completion is 2022-06-09.
What conditions does trial NCT05141903 study?
This clinical trial studies the following conditions: Healthy Adults.
What interventions are being tested in trial NCT05141903?
The interventions under investigation include: Probiotic (DIETARY_SUPPLEMENT), Antibiotic (DIETARY_SUPPLEMENT), HMO Concentrate (DIETARY_SUPPLEMENT), Food Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05141903?
This trial is sponsored by Prolacta Bioscience, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05141903 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05141903's enrollment target sits among peer trials
92 9th of 33 higher than 25 of 33 other Healthy Adults trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Adults 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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