Fecal Microbiota Transplantation for Health Improvement (TFM3)

Federal Research and Clinical Center of Physical-Chemical Medicine

Status: Unknown

Conditions: Irritable Bowel Syndrome; Irritable Bowel; Ulcerative Colitis; Crohn Disease

Treatments: Other: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04011943

TFM3

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 4 patient groups, including a placebo group

Participants with bowel diseases

Experimental group

Description:

Treatment by transplantation of fecal microbiota

Treatment:

Other: Fecal Microbiota Transplantation

autologous transplantation of fecal microbiota - healthy

Experimental group

Description:

Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules)

Treatment:

Other: Fecal Microbiota Transplantation

Both autologous and heterologous transplantation - healthy

Experimental group

Description:

Healthy volunteers will receive both autologous and heterologous transplantation (capsules)

Treatment:

Other: Fecal Microbiota Transplantation

placebo capsules - healthy

Placebo Comparator group

Description:

Healthy volunteers will receive placebo capsules

Treatment:

Other: Fecal Microbiota Transplantation