Clinical trials: Fecal Microbiota Therapy (FMT)
Clostridium Difficile Infection
A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection
This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for…
- Trial name
- FMTREAT (NCT03053505)
- Testing
- faecal human microbiota transplant (FMT), Vancomycin or Fidaxomicin
- Where
- 3 sites in Hungary
- Volunteers
- 150 people
- Sponsor
- Sejtterapia Kozpont Kft.
Leukemia, Myeloid, Acute
PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients
The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal…
- Trial name
- ODYSSEE (NCT02928523)
- Testing
- Autologous Fecal Microbiota Transplantation
- Where
- 4 sites in France
- Volunteers
- 20 people
- Sponsor
- MaaT Pharma
Clostridium Difficile Infection Recurrence
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy.
- Trial name
- CDI-SCOPE (NCT05831189)
- Testing
- RBX2660
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ferring Pharmaceuticals
Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI).
- Trial name
- NCT05201079
- Testing
- MBK-01, Fidaxomicin
- Where
- 21 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Recurrent Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium…
- Trial name
- PUNCH CD (NCT01925417)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 13 sites in United States
- Volunteers
- 34 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Fecal Microbiota Transplantation
Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder.
- Trial name
- NCT04861649
- Testing
- fecal microbiota transplantation
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Asclepius Meditec Inc.
Enterocolitis Clostridium Difficile Recurrent
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C.
- Trial name
- PUNCHCD2 (NCT02299570)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 21 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- Rebiotix Inc.
Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD
MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients
MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as…
- Trial name
- ARES (NCT04769895)
- Testing
- MaaT013
- Where
- 50 sites in Austria, Belgium and 4 more
- Volunteers
- 66 people
- Sponsor
- MaaT Pharma
Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated…
- Trial name
- NCT02589847
- Testing
- RBX2660, Standard of Care Antibiotics
- Where
- 30 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Rebiotix Inc.
Fecal Microbiota Transplantation
Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality.
- Trial name
- HERACLES (NCT03359980)
- Testing
- fecal microbiota transfer
- Where
- 16 sites in France, Italy and 1 more
- Volunteers
- 24 people
- Sponsor
- MaaT Pharma
Clostridium Difficile Infection Recurrence
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II.
- Trial name
- PRISM3 (NCT03110133)
- Testing
- Full Spectrum Microbiota
- Where
- 58 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Finch Research and Development LLC.
Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible…
- Conditions
- Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff, CDI
- Trial name
- PRISM-EXT (NCT03497806)
- Testing
- CP101
- Where
- 57 sites in United States, Canada
- Volunteers
- 132 people
- Sponsor
- Finch Research and Development LLC.
Diverticulitis, Diverticulitis of Sigmoid
Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis
Patients with diverticulitis experience a prolonged course of the disease and report a variety of physical, psychological and social symptoms, which highly impacts in their quality of life.
- Trial name
- NCT06687382
- Testing
- MBK-01
- Where
- Spain
- Volunteers
- 81 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.