Trials / Completed
CompletedNCT04552418
Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
Pilot Study of Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Potato starch | Starting 5-7 days before treatment with dual-ICI, participant will consume 20g of potato starch (Bob's Red Mill®) once a day for 3 days, then increase to 20g twice a day, continuing throughout dual-ICI treatment (total duration approximately 13 weeks). |
Timeline
- Start date
- 2021-06-02
- Primary completion
- 2023-01-24
- Completion
- 2023-01-24
- First posted
- 2020-09-17
- Last updated
- 2024-02-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04552418. Inclusion in this directory is not an endorsement.