Fecal Microbiota Transplantation for Health Improvement (TFM3)
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Irritable Bowel
- Irritable Bowel Syndrome
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: In total, 85 participants must be registered. 35 are healthy volunteers. Of these volunteers, 15 will receive autologous transplantation of fecal microbiota, 10 will receive both autologous and heterologous transplantation and 10 volunteers form a placebo-controlled group. 50 participants will form a treatment group.Masking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Objectives of the study: To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms. To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control. Create a bank...
Objectives of the study: To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms. To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control. Create a bank of fecal samples of healthy donors; Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers; Analyze the efficacy of therapy with TFM on the sample of patients; Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers; Analyze long-term effects in patients within 6 months after the TPM. The study is expected to include 50 patients, 35 healthy volunteers and healthy feces donors The study is scheduled to begin in May 2018, the supposed completion of the study is December 2020
Tracking Information
- NCT #
- NCT04011943
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Elena Ilina, MD FRCC PCM
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