Microbiome Modulation Trials Supported by PRIME-TR
Antibiotic Interventions
Dietary Interventions
BE GONE (Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects)
PI: Carrie Daniel-MacDougall, Ph.D., M.P.H.
NCT02843425
DIET (Impact of Prebiotic Food-Enriched Diet in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade in ICB-Refractory Melanoma Patients)
PI: Jennifer McQuade, M.D., M.Sc., M.A., LAc
NCT06250335
EnDVR 2.0 (Impact of High Dietary Fiber on Microbiome and Vaccine Responses)
This study is an expansion of EnDVR (Environmental Determinants Associated With Favorable Vaccine Response)
PI: Jennifer Wargo, M.D., M.M.Sc., FACS
NCT05565586
Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
PI: Justin Gregg, M.D.
NCT04985565
Fecal Microbiota Transplantations (FMT)
Fecal Microbiota Transplant and Re-Introduction of Anti-PD-1 Therapy for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-Responders
PI: Michael Overman, M.D.
NCT04729322
Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy
PI: Neeraj Saini, M.D.
NCT06218602
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
PI: Yinghong Wang, M.D., Ph.D., M.Sc.
NCT03819296
Frequently Asked Questions by Our Clinical Trial Participants
What are the benefits of collecting a biological sample?
Biospecimens provide information on the microbiome, which has direct applications for cancer onset, progression, and response to treatment across different types of caner.
I did not receive my kit. What should be done next?
You may contact PRIME-TR with any questions, including the status of your kit delivery. We can check its status via the courier service. If the kit has become lost in transit, we will readily provide you with another at no cost.
The outside of the kit's box says "PERISHABLE". Is this kit okay for use?
Yes, your kit can be used to collect your biospecimen. The "PERISHABLE" label is only relevant during return transport of your sample to our lab.
The kit instructions state that my biological sample should not be returned on a Friday or weekend. What should I do if I have already collected my sample?
You may keep your biospecimen in your refrigerator until you are able to ship it, preferably on the following Monday. If you are storing your biospecimen in your refrigerator, please ensure that it is securely closed and placed inside the provided biospecimen bag to avoid contamination. If your kit also includes ice packs, please keep these in your freezer until you are ready to package your refrigerated biospecimen for return shipment.
I have been asked to collect a stool sample but am worried about the consistency of my stool. Should I delay in collecting my stool sample?
You may provide stool of any consistency if there is enough quantity, as stipulated in your kit's instructions. If you have a colostomy bag, you can still provide a stool sample but you will need to provide the name of your colostomy bag's manufacturer on the "Stool Collection Form" included in your kit. This will ensure proper processing of your stool sample.