NCT03631823

Gut Microbiota and Glioblastoma Multiforme Prognosis

Status unknown Last updated 15 August 2018

What this trial tests

trial testing Chemotherapy with temozolomide or no chemotherapy in Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis in 200 participants. Status unknown.

Timeline

10 August 2018

Primary endpoint
10 August 2019

1 May 2020

Quick facts

Lead sponsor	Huashan Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	10 August 2018
Primary completion	10 August 2019
Estimated completion	1 May 2020

Drugs / interventions tested

• Chemotherapy with temozolomide or no chemotherapy

Conditions studied

• Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis — all drugs for Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis →

Sponsor

Huashan Hospital

Who can join

Adults 18 to 75, any sex, with Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Glioma is the most common primary cancer of the central nervous system, and around 50% of patients present with the most aggressive form of the disease, glioblastoma. Conventional therapies, including surgery, radiotherapy, and pharmacotherapy (typically chemotherapy with temozolomide), have not resulted in major improvements in the survival outcomes with only a median survival of around 15 months.The main reason may be related to the highly immunosuppressive tumor microenvironment. In recent years, the microbiome has emerged as a key regulator of not only systemic immune regulation but brain circuitry, neuro-physiology and microglia development. We hypothesized that there is a link between the gut microbiota and the GBM development and evolution through the immune regulation cells (microglia and tumor related macrophagocyte) in the blood circulation to impact the prognosis( PFS and MST) of GBM patients.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbiota and the gut-brain-axis: Implications for new therapeutic design in the CNS.
   Liu L, Huh JR, Shah K. · · 2022 · cited 199× · PMID 35255456 · DOI 10.1016/j.ebiom.2022.103908
2. Much More Than IL-17A: Cytokines of the IL-17 Family Between Microbiota and Cancer.
   Brevi A, Cogrossi LL, Grazia G, Masciovecchio D, et al · · 2020 · cited 81× · PMID 33244315 · DOI 10.3389/fimmu.2020.565470
3. The gut microbiome and response to immune checkpoint inhibitors: preclinical and clinical strategies.
   Gong J, Chehrazi-Raffle A, Placencio-Hickok V, Guan M, et al · · 2019 · cited 75× · PMID 30887236 · DOI 10.1186/s40169-019-0225-x
4. Monitoring and Modulating Diet and Gut Microbes to Enhance Response and Reduce Toxicity to Cancer Treatment.
   Knisely A, Seo YD, Wargo JA, Chelvanambi M. · · 2023 · cited 14× · PMID 36765735 · DOI 10.3390/cancers15030777
5. A Holistic Approach to Hard-to-Treat Cancers: The Future of Immunotherapy for Glioblastoma, Triple Negative Breast Cancer, and Advanced Prostate Cancer.
   Puig-Saenz C, Pearson JRD, Thomas JE, McArdle SEB. · · 2023 · cited 4× · PMID 37626597 · DOI 10.3390/biomedicines11082100
6. Deciphering the intratumor microbiota in malignant gastrointestinal tumors: multifaceted interplay and clinical implications.
   Tang B, Lin Y, Jiang T, Chen Y, et al · · 2026 · cited 1× · PMID 41593640 · DOI 10.1186/s12964-025-02303-y
7. The Gut-Brain-Immune Axis in Glioma: Emerging Mechanisms and Therapeutic Opportunities.
   Feng R, Yang Z, Zhou Y, Zhao H. · · 2026 · PMID 41677988 · DOI 10.1007/s10571-026-01680-3