Table 1.
Clinical trials that aim to modify cancer outcomes via the microbiome
| NCT# | Age Range | Description | Location | Lead Investigator | Status | Time frame |
|---|---|---|---|---|---|---|
|
| ||||||
| NCT04267874 | 55 –77 A, OA | Black raspberry diet intervention for MB modification and LC prevention. | OSUCCC | D. Spakowicz | R | 10/19–12/22 |
| NCT04229381 | 60+ A, OA | Physical therapy and stress intervention to improve resiliency in LC patients. | OSUCCC | C. Presley | R | 1/20–12/21 |
| NCT02791737 | 60+ A, OA | Exercise intervention to improve physical activity in cancer patients. | OSUCCC | A. Rosko | N | 7/16–12/20 |
| NCT03686202 | 18+ A, OA | Assess efficacy of microbial ecosystem therapeutics in altering IO response. | Princess Margaret CC | L. Siu A. Spreafico | N | 11/18–12/23 |
| NCT03772899 | 19+ A, OA | Assess combination FMT and IO can enhance antitumor effects in melanoma. | LRCP | J. Lenehan | R | 3/19–12/23 |
| NCT03817125 | 18+ A, OA | Assess safety and tolerability of oral MB intervention in combination with PD-1 inhibitors in melanoma patients. | Angeles Clinic & Research Institute (& others) | R. Ibrahim (& others) | R | 1/19–2/22 |
| NCT04163289 | 18+ A, OA | Assess safety of FMT combination treatment in reducing the occurrence of immune-related toxicities. | LRCP | R. Fernandes S. Maleki | R | 1/20–11/28 |
| NCT04056026 | Y, A, OA | Enhance the MB via FMT to improve the efficacy PD-1 inhibitors. | ProgenaBiome | Progena Biome | C | 9/18–12/18 |
| NCT04130763 | 18–70 A, OA | Assess if FMT capsules improve anti-PD-1 response. | Beijing Cancer Hospital | L. Shen | R | 12/19–10/20 |
| NCT04116775 | 18+ A, OA | Assess effect of FMT from responders to PD-1 inhibitors into non-responders in PCA patients. | VA Portland Health Care System | J. N Graff | R | 10/19–10/23 |
| NCT03819296 | 18+ A, OA | Assess role of MB and FMT on medication colitis in cancer patients. | MD Anderson CC | Y. Wang | X | 2/20–7/22 |
| NCT03353402 | 18+ A, OA | Assess effect of FMT from responders to PD-1 inhibitors into non-responders in melanoma patients. | Sheba MC | G. Markel | R | 11/17–12/21 |
| NCT03341143 | 18+ A, OA | Assess if FMT improves the body’s ability to fight melanoma. | UPMC Hillman CC | D. Davar | S | 1/18–10/20 |
| NCT02843425 | 30+ A, OA | Assess if beans can increase healthy bacteria and reduce the effects of obesity on cancer risk. | MD Anderson CC | C. Daniel-MacDougall | N | 7/16–7/25 |
| NCT01929122 | 18+ A, OA | Assess effects of bean powder or rice bran on the MB and metabolome of CRC survivors and healthy adults. | Colorado State Poudre Valley Hospital | E. P Ryan | C | 8/10–12/14 |
| NCT04079270 | 18+ A, OA | Assess effect of diet intervention on breast cancer outcomes and biomarkers. | Sheba MC | E. Gal-Yam | R | 7/19–12/25 |
| NCT03782428 | 18+ A, OA | Assess the role of probiotics in reducing CRC related inflammatory markers. | National University of Malaysia | R. Affendi R. Ali | C | 8/16–11/18 |
| NCT03661047 | 18+ A, OA | Assess effects of omega-3 oil on tumor immune microenvironment in CCR. | Massachusetts General Hospital | M. Song | R | 11/19–9/23 |
| NCT03781778 | 18+ A, OA | Assess effect of resistant starch on inflammation and MB in CCR survivors. | Fred Hutch/UW Cancer Consortium | M. Neuhouser | S | 5/19–9/20 |
| NCT03448003 | 18 + A, OA | Assess if comprehensive lifestyle changes can prevent breast cancer. | MD Anderson CC | L. Cohen | R | 4/19–9/22 |
| NCT03358511 | 18 + A, OA | Assess effect of probiotics on breast cancer immune response. | Mayo Clinic | S. Chumsri | C | 10/17–5/20 |
| NCT03028831 | 40–65 A, OA | Fiber based intervention of the typical native Alaskan diet for MB modification and CRC reduction. | AK Native Tribal Health Consortium Pitt | G. Riscuta | R | 12/17–1/22 |
| NCT03290651 | Y, A, OA | Probiotic intervention for displacement of cancer related inflammatory bacteria. | St. Joseph’s Health Care | G. Reid M. Brackstone | R | 7/19–12/21 |
| NCT03853928 | 18 + A, OA | Assess if probiotic intervention in patients with cirrhosis alters incidence of HCC. | Austral University (sponsor) | F. Piñero | X | 5/19–5/23 |
| NCT03268655 | 50–75 A, OA | Assess if ginger can create an anti-inflammatory, CRC-protective MB | Mayo Clinic CC (and others) | A. Prizment | C | 11/18–6/20 |
Abbreviations: OSUCCC = Ohio State University Comprehensive Cancer Center; CC = Cancer center; MC = Medical center; LRCP = London Regional Cancer Program; A = Adult; OA = Older adult; Y = Child; R = Recruiting; S = Suspended; N = Active not recruiting; C = Completed; X = Not yet recruiting; FMT = Fecal microbiota transplantation; IO = Immuno-oncology or immunotherapy; CRC = Colorectal cancer; HCC = Hepatocellular carcinoma; PCA = Prostate cancer; MB = Microbiome; LC = Lung cancer