Fecal Microbiota Transplantation for Health Improvement (TFM3)

Ulcerative Colitis Clinical Trial

— TFM3  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04011943
• Other study ID #: TFM3
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2019
• Source: Federal Research and Clinical Center of Physical-Chemical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• the age of patients - from 18 to 75 years, both sexes;

• Patients with:

• antibiotic-associated colitis,

• inflammatory bowel diseases (ulcerative colitis, Crohn's disease),

• diseases caused by C. difficile infection,

• a syndrome of impaired intestinal absorption,

• irritable bowel syndrome,

• celiac disease (severe form),

• metabolic syndrome, including diabetes mellitus type II,

• Atopic dermatitis with damage to the mucous membrane of the colon,

• hepatitis of various etiologies,

• cirrhosis of the liver of various etiologies

• pancreatitis of various etiologies,

• Absence of contraindications to gastroscopy

• informed consent of the patient for the transplant procedure

Exclusion Criteria:

• the presence of a concomitant chronic infectious or neoplastic disease in the patient

• Patients with a proven allergy to foods not excluded from the donor's diet

• absence of the patient for one or more intermediate stages of the examination.

• informed refusal to continue therapy

Related Conditions & MeSH terms

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

Intervention

Other:
• Fecal Microbiota Transplantation
Fecal Microbiota Transplantation

Locations

Country	Name	City	State
Russian Federation	FRCC PCM	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research and Clinical Center of Physical-Chemical Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcerative Colitis remission	Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index <3	1 month after transplantation. Change from Baseline - 1 day before transplantation
Primary	Crohn Disease remission	Crohn Disease remission defined as a Harvey-bradshaw index <3.	1 month after transplantation. Change from Baseline - 1 day before transplantation.
Secondary	Improvement in Ulcerative Colitis symptoms.	Defined as improvement in SCCAI.	1 month after transplantation. Change from Baseline - 1 day before transplantation.
Secondary	Change in gut microbiome	Diversity and variability of gut microbiome.	1 month after transplantation. Change from Baseline - 1 day before transplantation.