Fecal Microbiota Transplantation for Health Improvement (TFM3)

• Sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04011943
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 30.4
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis; Irritable Bowel Syndrome; Crohn Disease; Irritable Bowel	Other: Fecal Microbiota Transplantation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 21, 2018
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with bowel diseases Treatment by transplantation of fecal microbiota	Other: Fecal Microbiota Transplantation; Fecal Microbiota Transplantation
Experimental: autologous transplantation of fecal microbiota - healthy Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules)	Other: Fecal Microbiota Transplantation; Fecal Microbiota Transplantation
Experimental: Both autologous and heterologous transplantation - healthy Healthy volunteers will receive both autologous and heterologous transplantation (capsules)	Other: Fecal Microbiota Transplantation; Fecal Microbiota Transplantation
Placebo Comparator: placebo capsules - healthy Healthy volunteers will receive placebo capsules	Other: Fecal Microbiota Transplantation; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. Improvement in Ulcerative Colitis symptoms. [1 month after transplantation. Change from Baseline - 1 day before transplantation.]

   Defined as improvement in SCCAI.

2. Change in gut microbiome [1 month after transplantation. Change from Baseline - 1 day before transplantation.]

   Diversity and variability of gut microbiome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FRCC PCM	Moscow		Russian Federation

Sponsors and Collaborators

• Federal Research and Clinical Center of Physical-Chemical Medicine

Investigators

• Principal Investigator: Elena Ilina, MD, FRCC PCM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Federal Research and Clinical Center of Physical-Chemical Medicine
• ClinicalTrials.gov Identifier: NCT04011943
• Other Study ID Numbers: TFM3
• First Posted: Jul 9, 2019
• Last Update Posted: Jul 9, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease; Irritable Bowel Syndrome

Study Results

No Results Posted as of Jul 9, 2019