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NCT04552418 · ClinicalTrials.gov registry record · Early Phase 1
Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
A Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT04552418: Completed Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT04552418 is a Early Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04552418, a Early Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a pilot study designed to assess the safety and feasibility of administering a dietary supplement to patients undergoing cancer treatment with a dual immune checkpoint inhibitors (ICIs) for solid cancer.
Primary Outcome
Feasibility will be determined by calculating the number of patients who have taken 70% or more of scheduled dose of dietary intervention. Patients will be asked to record doses of starch taken and will be provided a table in which doses can be checked off.
Interventions
- DRUG Potato starch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-06-02 |
| Est. Completion | 2023-01-24 |
| Phase | Early Phase 1 |
What the finished NCT04552418 record still lists
NCT04552418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Potato starch is the first listed.
NCT04552418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04552418 about?
NCT04552418 is a clinical study titled "Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors". This is a pilot study designed to assess the safety and feasibility of administering a dietary supplement to patients undergoing cancer treatment with a dual immune checkpoint inhibitors (ICIs) for solid cancer.
What is the current status of trial NCT04552418?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-06-02. Estimated completion is 2023-01-24.
What interventions are being tested in trial NCT04552418?
The interventions under investigation include: Potato starch (DRUG).
Who is sponsoring clinical trial NCT04552418?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04552418's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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