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NCT05793112 · ClinicalTrials.gov registry record · Phase 4
INF108F in Infants With Food Protein Induced Proctocolitis
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT05793112: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT05793112 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05793112, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
Primary Outcome
Absolute change from baseline in relative abundance of B. infantis INF108F to Study Day 28 via metagenomics results in mITT population. Unit measured: The absolute change from baseline in the percentage of sequenced reads assigned to B. infantis INF108F (calculated as value at Day 28 - value at baseline).
Interventions
- DRUG Placebo
- DRUG INF108F probiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-09-09 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 4 |
What the finished NCT05793112 record still lists
NCT05793112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05793112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05793112 about?
NCT05793112 is a clinical study titled "INF108F in Infants With Food Protein Induced Proctocolitis". Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
What is the current status of trial NCT05793112?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2023-09-09. Estimated completion is 2024-09-27.
What interventions are being tested in trial NCT05793112?
The interventions under investigation include: Placebo (DRUG), INF108F probiotic (DRUG).
Who is sponsoring clinical trial NCT05793112?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05793112's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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