NCT04011943

Fecal Microbiota Transplantation for Health Improvement (TFM3)

Study of the Effects of Fecal Microbiota Transplantation for Correction of the Physiological State of the Human Body in Norm and in Pathology

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.

Detailed description

Objectives of the study: 1. To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms. 2. To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control. 3. Create a bank of fecal samples of healthy donors; 4. Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers; 5. Analyze the efficacy of therapy with TFM on the sample of patients; 6. Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers; 7. 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

Conditions

• Ulcerative Colitis
• Irritable Bowel Syndrome
• Crohn Disease
• Irritable Bowel

Interventions

Type	Name	Description
OTHER	Fecal Microbiota Transplantation	Fecal Microbiota Transplantation

Timeline

• Start date: 2018-05-21
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-07-09
• Last updated: 2019-07-09

Locations

1 site across 1 country: Russia