Clinical trial NCT04011943: Fecal Microbiota Transplantation for Health Improvement (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Irritable Bowel Syndrome
Crohn Disease
Irritable Bowel
Lead sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ulcerative Colitis remission
timeFrame: 1 month after transplantation. Change from Baseline - 1 day before transplantation
measure: Crohn Disease remission
timeFrame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Secondary outcomes:
measure: Improvement in Ulcerative Colitis symptoms.
timeFrame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
measure: Change in gut microbiome
timeFrame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: FRCC PCM
Study officials:
affiliation: FRCC PCM
name: Elena Ilina, MD
role: PRINCIPAL_INVESTIGATOR
References: