Fecal Microbiota Transplantation for Health Improvement (TFM3)

NCT04011943 | Unknown

• 1 other identifier: TFM3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Improvement in Ulcerative Colitis symptoms.

  1 month after transplantation. Change from Baseline - 1 day before transplantation.

• Change in gut microbiome

  1 month after transplantation. Change from Baseline - 1 day before transplantation.

Study Arms (4)

Participants with bowel diseases

EXPERIMENTAL

Treatment by transplantation of fecal microbiota

Other: Fecal Microbiota Transplantation

autologous transplantation of fecal microbiota - healthy

EXPERIMENTAL

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

Other: Fecal Microbiota Transplantation

Both autologous and heterologous transplantation - healthy

EXPERIMENTAL

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

Other: Fecal Microbiota Transplantation

placebo capsules - healthy

PLACEBO COMPARATOR

Healthy volunteers will receive placebo capsules

Other: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation OTHER

Fecal Microbiota Transplantation

Both autologous and heterologous transplantation - healthy; Participants with bowel diseases; autologous transplantation of fecal microbiota - healthy; placebo capsules - healthy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research and Clinical Center of Physical-Chemical Medicine: lead

Study Sites (1)

FRCC PCM

Moscow, Russia

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Irritable Bowel Syndrome; Crohn Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Colonic Diseases, Functional

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Elena Ilina, MD

  FRCC PCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: July 9, 2019
• Study Start: May 21, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)