^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    Microbiome modulator

    Related drugs:
    4d
    PROREDI: Study to Evaluate the Treatment Benefits of Probiotic Clostridium Butyricum CBM588® for IBS-D (clinicaltrials.gov)
    P=N/A, N=400, Completed, Liaquat University of Medical & Health Sciences | Trial completion date: Sep 2024 --> Mar 2025 | Initiation date: Sep 2023 --> Nov 2024 | Trial primary completion date: Mar 2024 --> Feb 2025
    Trial completion date • Trial initiation date • Trial primary completion date • HEOR
    |
    Cdactin-O (CBM588)
    4d
    Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer (clinicaltrials.gov)
    P2, N=88, Recruiting, Virginia Commonwealth University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    irinotecan • aspirin
    9d
    ENDB-009-23F: Fiber and Calcium Absorption in Older Men (clinicaltrials.gov)
    P2, N=30, Recruiting, VA Office of Research and Development | Not yet recruiting --> Recruiting
    Enrollment open
    9d
    PROREDI: Study to Evaluate the Treatment Benefits of Probiotic Clostridium Butyricum CBM588® for IBS-D (clinicaltrials.gov)
    P=N/A, N=400, Completed, Liaquat University of Medical & Health Sciences | N=200 --> 400
    Enrollment change • HEOR
    |
    Cdactin-O (CBM588)
    18d
    CBM588 Reduces Colorectal Polyp Recurrence (clinicaltrials.gov)
    P=N/A, N=500, Enrolling by invitation, Kaohsiung Medical University
    New trial
    |
    Cdactin-O (CBM588)
    23d
    CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    TNFA (Tumor Necrosis Factor-Alpha) • TNFRSF1A (TNF Receptor Superfamily Member 1A) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Cdactin-O (CBM588)
    1m
    Effects of Microbiome Modulation on Sleep in Working People (clinicaltrials.gov)
    P=N/A, N=100, Active, not recruiting, Medical University of Graz | Trial primary completion date: Dec 2024 --> Jul 2025
    Trial primary completion date
    1m
    ROAR: REBYOTA™ Prospective Registry (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, Ferring Pharmaceuticals | N=500 --> 200 | Trial completion date: Aug 2025 --> Apr 2026 | Trial primary completion date: Jul 2025 --> Feb 2026
    Enrollment change • Trial completion date • Trial primary completion date
    1m
    A Study of Microbiome Transplantation for the Treatment of Constipation in Patients with Systemic Sclerosis (clinicaltrials.gov)
    P2, N=21, Not yet recruiting, The University of Texas Health Science Center, Houston
    New P2 trial
    1m
    GB-X01-101: Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer (clinicaltrials.gov)
    P1, N=9, Completed, GI Biome, Inc. | Recruiting --> Completed | N=18 --> 9
    Trial completion • Enrollment change
    |
    GB104
    1m
    Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease (clinicaltrials.gov)
    P=N/A, N=194, Active, not recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Oct 2024 --> Nov 2027 | Trial primary completion date: Oct 2024 --> Nov 2027
    Trial completion date • Trial primary completion date
    2ms
    A Study of SER-155 to Treat Diarrhea in People on Immunotherapy (clinicaltrials.gov)
    P1, N=15, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1 trial
    2ms
    Deciphering the therapeutic effects of Xiyanping injection: insights into pulmonary and gut microbiome modulation, SerpinB2/PAI-2 targeting, and alleviation of influenza a virus-induced lung injury. (PubMed, Virol J)
    Finally, human protein chips and molecular docking were carried out to confirm the binding of the main component of XYP injection, andrographolide, with SERPINB2/PAI-2 protein. Overall, our study provides valuable insights into the therapeutic potential of XYP injection in treating influenza, highlighting its multifaceted effects on host microbiota and immune responses, and pinpointing SerpinB2/PAI-2 as the target for XYP injection in exerting anti-inflammatory and antiviral therapeutic mechanisms.
    Journal
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL18 (Interleukin 18) • CXCL5 (Chemokine (C-X-C motif) ligand 5) • IL15 (Interleukin 15) • IL5 (Interleukin 5)
    2ms
    Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, AC Camargo Cancer Center
    New P2 trial
    2ms
    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, Completed, Ferring Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    2ms
    Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer (clinicaltrials.gov)
    P2, N=88, Not yet recruiting, Virginia Commonwealth University | Trial completion date: Apr 2035 --> Jul 2035 | Initiation date: Dec 2024 --> Mar 2025 | Trial primary completion date: Apr 2035 --> Jul 2035
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    irinotecan • aspirin
    2ms
    A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis (clinicaltrials.gov)
    P2, N=80, Completed, KoBioLabs | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Oct 2024
    Trial completion • Trial completion date
    3ms
    A Phase 2 Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Adult Patients with Active Mild to Moderate Ulcerative Colitis (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Guangzhou Zhiyi Biotechnology Co., Ltd. | Trial completion date: Aug 2025 --> Aug 2027 | Trial primary completion date: Jul 2025 --> Jul 2027
    Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    3ms
    Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial) (clinicaltrials.gov)
    P2, N=387, Recruiting, MaaT Pharma | Phase classification: P2b --> P2
    Phase classification
    |
    MaaT033
    3ms
    LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC) (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Liveome Inc.
    New P1 trial
    3ms
    A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC) (clinicaltrials.gov)
    P1, N=38, Completed, Liveome Inc. | Recruiting --> Completed | Trial completion date: Jul 2024 --> Mar 2024
    Trial completion • Trial completion date
    3ms
    EnSync: Topical ENS-002 for Atopic Dermatitis in Adults (clinicaltrials.gov)
    P1, N=9, Recruiting, Concerto Biosciences | Trial completion date: Dec 2024 --> May 2025 | Trial primary completion date: Dec 2024 --> May 2025
    Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    3ms
    Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer (clinicaltrials.gov)
    P2, N=88, Not yet recruiting, Virginia Commonwealth University
    New P2 trial • Metastases
    |
    irinotecan • aspirin
    3ms
    A Phase 2 Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Adult Patients with Active Mild to Moderate Ulcerative Colitis (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Guangzhou Zhiyi Biotechnology Co., Ltd.
    New P2 trial
    |
    CRP (C-reactive protein)
    3ms
    CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Brigham and Women's Hospital | Recruiting --> Active, not recruiting
    Enrollment closed
    4ms
    JAK-FMT: Fecal Microbiota Transplantation With Ruxolitinib and Steroids as an Upfront Treatment of Severe Acute Intestinal GVHD (clinicaltrials.gov)
    P1/2, N=2, Terminated, St. Petersburg State Pavlov Medical University | N=20 --> 2 | Trial completion date: Dec 2025 --> Nov 2024 | Recruiting --> Terminated; Poor recruitment
    Enrollment change • Trial completion date • Trial termination • Combination therapy
    |
    Jakafi (ruxolitinib)
    4ms
    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, Recruiting, Microbiotica Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    4ms
    A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC (clinicaltrials.gov)
    P2, N=87, Not yet recruiting, LISCure Biosciences
    New P2 trial
    4ms
    SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov)
    P1/2, N=36, Active, not recruiting, Theriva Biologics, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2a --> P1/2 | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment closed • Phase classification • Trial completion date • Trial primary completion date
    4ms
    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 primary completion date: Oct 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    5ms
    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)
    5ms
    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
    5ms
    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
    5ms
    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
    5ms
    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
    6ms
    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
    6ms
    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
    6ms
    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
    6ms
    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
    6ms
    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
    6ms
    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)
    6ms
    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)