Fecal Microbiota Transplantation for Health Improvement (TFM3)

Not Applicable

• Conditions: Crohn Disease; Irritable Bowel Syndrome; Ulcerative Colitis; Irritable Bowel
• Interventions: Other: Fecal Microbiota Transplantation

• Registration Number: NCT04011943
• Lead Sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine

Brief 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

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2019-05-17
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-04
• Last Update Submitted: 2019-07-04
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with bowel diseases	Fecal Microbiota Transplantation	Treatment by transplantation of fecal microbiota
placebo capsules - healthy	Fecal Microbiota Transplantation	Healthy volunteers will receive placebo capsules
Both autologous and heterologous transplantation - healthy	Fecal Microbiota Transplantation	Healthy volunteers will receive both autologous and heterologous transplantation (capsules)
autologous transplantation of fecal microbiota - healthy	Fecal Microbiota Transplantation	Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules)

Primary Outcome Measures

Name	Time	Method
Ulcerative Colitis remission	1 month after transplantation. Change from Baseline - 1 day before transplantation	Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index \<3
Crohn Disease remission	1 month after transplantation. Change from Baseline - 1 day before transplantation.	Crohn Disease remission defined as a Harvey-bradshaw index \<3.

Secondary Outcome Measures

Name	Time	Method
Change in gut microbiome	1 month after transplantation. Change from Baseline - 1 day before transplantation.	Diversity and variability of gut microbiome.
Improvement in Ulcerative Colitis symptoms.	1 month after transplantation. Change from Baseline - 1 day before transplantation.	Defined as improvement in SCCAI.

Trial Locations

Locations (1)

FRCC PCM; 🇷🇺 Moscow, Russian Federation