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    DRUG CLASS:

    Microbiome modulator

    Related drugs:
    2d
    R-3750 in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov)
    P1, N=36, Recruiting, Rise Therapeutics LLC | Trial completion date: Feb 2025 --> Oct 2025
    Trial completion date
    9d
    PROREDI: Study to Evaluate the Treatment Benefits of Probiotic Clostridium Butyricum CBM588® for IBS-D (clinicaltrials.gov)
    P=N/A, N=200, Completed, Liaquat University of Medical & Health Sciences
    New trial • HEOR
    |
    Cdactin-O (CBM588)
    11d
    Fiber and Calcium Absorption in Older Men (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, VA Office of Research and Development | Trial completion date: Sep 2029 --> Jan 2029 | Initiation date: Sep 2024 --> Jan 2025 | Trial primary completion date: Sep 2029 --> Jan 2029
    Trial completion date • Trial initiation date • Trial primary completion date
    28d
    A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov)
    P1, N=0, Withdrawn, Ferring Pharmaceuticals | N=90 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    28d
    ARES: MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients (clinicaltrials.gov)
    P3, N=66, Active, not recruiting, MaaT Pharma | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Nov 2025 | Trial primary completion date: Sep 2023 --> Nov 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Jakafi (ruxolitinib) • MaaT013
    1m
    Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=25, Recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Jul 2025 --> Apr 2028 | Trial primary completion date: Dec 2024 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    CD38 (CD38 Molecule) • IL2RA (Interleukin 2 receptor, alpha) • CD69 (CD69 Molecule) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium
    1m
    SER-155-001: A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT (clinicaltrials.gov)
    P1, N=60, Completed, Seres Therapeutics, Inc. | Active, not recruiting --> Completed
    Trial completion
    2ms
    A Phase 1b Study to Evaluate the Safety of XEN-101 (clinicaltrials.gov)
    P1, N=33, Terminated, Xeno Biosciences | Data were reviewed after the first 23 patients had completed scheduled dosing and there was no signal of efficacy for change in body weight. This clinical trial has been determined to be futile.
    Trial termination
    2ms
    Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti- PD-1 (clinicaltrials.gov)
    P1, N=10, Completed, Peking University | Active, not recruiting --> Completed
    Trial completion
    2ms
    Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV (clinicaltrials.gov)
    P2, N=630, Suspended, Kibow Pharma | Trial completion date: Dec 2023 --> Dec 2025 | Recruiting --> Suspended | Trial primary completion date: Sep 2023 --> Sep 2025
    Trial completion date • Trial suspension • Trial primary completion date • Metastases
    2ms
    Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study (clinicaltrials.gov)
    P2/3, N=600, Suspended, Kibow Pharma | Trial completion date: Mar 2024 --> Mar 2026 | Recruiting --> Suspended | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial suspension • Trial primary completion date
    2ms
    Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function (clinicaltrials.gov)
    P1, N=12, Completed, Indiana University | Phase classification: P3 --> P1
    Phase classification
    |
    IL2RA (Interleukin 2 receptor, alpha) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
    2ms
    Inflammation mediated by gut microbiome alterations promotes lung cancer development and an immunosuppressed tumor microenvironment. (PubMed, Cancer Immunol Res)
    Here, we investigated the role of gut microbiome changes in LUAD development using fecal microbiota transfer and delineated a pathway by which gut microbiome alterations incurred by loss of Lcn2 fostered the proliferation of pro-inflammatory bacteria of the genus Alistipes, triggering gut inflammation...Corroborating our preclinical findings, we found that patients with LUAD with a higher relative abundance of Alistipes species in the gut showed diminished response to neoadjuvant immunotherapy. These insights reveal the role of microbiome-induced inflammation in LUAD and present new potential targets for interception and therapy.
    Journal
    |
    IL6 (Interleukin 6)
    2ms
    COMPOSER-1: A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Microbiotica Ltd
    New P1 trial
    3ms
    High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial (clinicaltrials.gov)
    P=N/A, N=40, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open
    3ms
    Diet Supplementation With Prebiotics to Improve Gut Health in Egyptian Children (clinicaltrials.gov)
    P=N/A, N=72, Recruiting, National Research Centre, Egypt
    New trial
    3ms
    Aloe-emodin alleviates inflammatory bowel disease in mice by modulating intestinal microbiome homeostasis via the IL-4/IL-13 axis. (PubMed, Heliyon)
    Finally, we found that overexpression of IL-4 was able to reverse the therapeutic effect of AE for DSS-induced IBD. AE shows promise in alleviating colitis severity, influencing inflammatory cytokines, and modulating the gut microbiota in an IBD mouse model via the IL-4/IL-13 pathway, suggesting its potential as a natural IBD remedy.
    Preclinical • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL17A (Interleukin 17A) • LCN2 (Lipocalin-2) • IL13 (Interleukin 13) • IL4 (Interleukin 4) • CAT (Catalase)
    3ms
    Total flavonoids of litchi Seed alleviates schistosomiasis liver fibrosis in mice by suppressing hepatic stellate cells activation and modulating the gut microbiomes. (PubMed, Biomed Pharmacother)
    Gut microbes metagenomics study revealed that the composition, abundance, and functions of the mice gut microbiomes changed significantly after S. japonicum infection, and TLF treatment reversed these changes. Therefore, our study indicated that TFL alleviated granulomatous lesions and improved S. japonicum induced liver fibrosis in mice by inhibiting the activation of HSCs and by improving the gut microbiomes.
    Preclinical • Journal
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • TGFB1 (Transforming Growth Factor Beta 1) • IL1B (Interleukin 1, beta) • IL4 (Interleukin 4)
    4ms
    Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov)
    P2, N=8, Active, not recruiting, University of Chicago | Suspended --> Active, not recruiting
    Enrollment closed • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • EDP1503
    4ms
    EnSync: Topical ENS-002 for Atopic Dermatitis in Adults (clinicaltrials.gov)
    P1, N=9, Recruiting, Concerto Biosciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CRP (C-reactive protein)
    4ms
    Gastroprotective and microbiome-modulating effects of ubiquinol in rats with radiation-induced enteropathy. (PubMed, Anim Microbiome)
    Fecal microbiota profiling revealed a dysbiosis state with a reduction of bacterial diversity post-irradiation, which was re-modulated in the Ubq treated groups to profiles that are indistinguishable from the control group. These findings underscore Ubq's gastroprotective effects against radiation-induced enteritis and its potential in restoring the gut microbiota's diversity and balance.
    Preclinical • Journal
    |
    CASP3 (Caspase 3) • IL1B (Interleukin 1, beta) • ALPL (Alkaline Phosphatase)
    4ms
    Effects of Microbiome Modulation on Sleep in Working People (clinicaltrials.gov)
    P=N/A, N=100, Active, not recruiting, Medical University of Graz | Recruiting --> Active, not recruiting | Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: May 2024 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    4ms
    Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis (clinicaltrials.gov)
    P1/2, N=52, Active, not recruiting, Intralytix, Inc. | Trial primary completion date: Jun 2025 --> Dec 2024 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial primary completion date
    4ms
    P30CA033572: CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer (clinicaltrials.gov)
    P1, N=30, Completed, City of Hope Medical Center | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cdactin-O (CBM588)
    5ms
    CDI-SCOPE: A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection (clinicaltrials.gov)
    P3, N=41, Active, not recruiting, Ferring Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    5ms
    EnSync: Topical ENS-002 for Atopic Dermatitis in Adults (clinicaltrials.gov)
    P1, N=9, Not yet recruiting, Concerto Biosciences
    New P1 trial
    |
    CRP (C-reactive protein)
    5ms
    RESIST-PTSD: Microbiome Modulation With Prebiotics in PTSD and Cirrhosis (clinicaltrials.gov)
    P=N/A, N=30, Recruiting, Hunter Holmes Mcguire Veteran Affairs Medical Center
    New trial
    5ms
    The Role of Tumor and Host Microbiome on Immunotherapy Response in Urologic Cancers. (PubMed, J Cancer Immunol (Wilmington))
    In advanced renal cell carcinoma, studies show that recent antibiotic administration negatively impacts survival outcomes in patients undergoing immunotherapy, while administration of CBM588, a live bacterial product, is associated with improved progression-free survival. Specific bacterial taxa, such as Streptococcus salivarius, have been linked with response to pembrolizumab in metastatic castrate-resistant prostate cancer...Although the exact mechanism is unclear, several studies identify a symbiotic relationship between microbiota-centered interventions and immunotherapy efficacy. It is possible to improve immunotherapy responsiveness in genitourinary malignancies using the microbiome, but further research with more standardized methodology is warranted.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Cdactin-O (CBM588)
    5ms
    IASO: Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, MaaT Pharma | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    MaaT033
    6ms
    A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov)
    P1, N=90, Recruiting, Ferring Pharmaceuticals | Trial completion date: Sep 2025 --> Jan 2026 | Trial primary completion date: Sep 2025 --> Jan 2026
    Trial completion date • Trial primary completion date
    6ms
    A Phase 1b Study to Evaluate the Safety of XEN-101 (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Xeno Biosciences
    New P1 trial
    6ms
    Dose Finding Study of CBM588 in Combination With Nivolumab/Ipilimumab in Advanced Stage Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=28, Recruiting, Osel, Inc.
    New P1 trial • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cdactin-O (CBM588)
    6ms
    RESTORATiVE303: VE303 for Prevention of Recurrent Clostridioides Difficile Infection (clinicaltrials.gov)
    P3, N=852, Recruiting, Vedanta Biosciences, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    6ms
    A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease (clinicaltrials.gov)
    P2, N=0, Withdrawn, The University of Texas Health Science Center, Houston | N=12 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    6ms
    Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis (clinicaltrials.gov)
    P1, N=20, Recruiting, The University of Texas Health Science Center, Houston | Not yet recruiting --> Recruiting
    Enrollment open
    6ms
    VE303 for Treatment of Hepatic Encephalopathy (HE) (clinicaltrials.gov)
    P2, N=19, Completed, Patricia Bloom | Active, not recruiting --> Completed
    Trial completion
    7ms
    CBM588 in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer (clinicaltrials.gov)
    P1, N=28, Recruiting, City of Hope Medical Center
    New P1 trial • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar) • Cdactin-O (CBM588)
    7ms
    Use of a novel microbiome modulator improves anticancer immunity in a murine model of malignant pleural mesothelioma. (PubMed, JTCVS Open)
    MMC administration boosts antitumor immunity, which correlates with a change in gut microbiome and metabolome. MMC may represent a valuable treatment option to combine with immunotherapy in patients with cancer.
    Preclinical • Journal
    |
    CD8 (cluster of differentiation 8)
    7ms
    SER-155-001: A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Seres Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    7ms
    CDI-SCOPE: A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection (clinicaltrials.gov)
    P3, N=40, Recruiting, Ferring Pharmaceuticals | Trial completion date: Sep 2024 --> Jan 2025 | Trial primary completion date: Sep 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    7ms
    IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study (clinicaltrials.gov)
    P3, N=2158, Active, not recruiting, Infant Bacterial Therapeutics | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Nov 2023 --> Jun 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    7ms
    A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov)
    P1, N=90, Recruiting, Ferring Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open