Ulcerative ColitisTFM3NCT04011943
Fecal Microbiota Transplantation for Health Improvement (TFM3)
A study testing Fecal Microbiota Transplantation in people with Ulcerative Colitis and Irritable Bowel Syndrome, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 1 site in Russia.
Trial summary
Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Irritable Bowel Syndrome, Crohn Disease
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 21 May 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.
Read the detailed description
Objectives of the study:
- To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms.
- To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control.
- Create a bank of fecal samples of healthy donors;
- Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers;
- Analyze the efficacy of therapy with TFM on the sample of patients;
- Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers;
- 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
- Being tested
- Fecal Microbiota Transplantation
- Medical subject headings
- Colitis, Ulcerative, Irritable Bowel Syndrome, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationOther
Fecal Microbiota Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Participants with bowel diseases | Experimental | Treatment by transplantation of fecal microbiota Receives: Other: Fecal Microbiota Transplantation |
| autologous transplantation of fecal microbiota - healthy | Experimental | Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules) Receives: Other: Fecal Microbiota Transplantation |
| Both autologous and heterologous transplantation - healthy | Experimental | Healthy volunteers will receive both autologous and heterologous transplantation (capsules) Receives: Other: Fecal Microbiota Transplantation |
| placebo capsules - healthy | Placebo comparator | Healthy volunteers will receive placebo capsules Receives: Other: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcerative Colitis remission
Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index <3
Measured: 1 month after transplantation. Change from Baseline - 1 day before transplantation
Crohn Disease remission
Crohn Disease remission defined as a Harvey-bradshaw index <3.
Measured: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Secondary outcomes (2)
Improvement in Ulcerative Colitis symptoms.
Defined as improvement in SCCAI.
Measured: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Change in gut microbiome
Diversity and variability of gut microbiome.
Measured: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start21 May 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Center of Physical-Chemical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Ilina, MD, Principal investigator, FRCC PCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011943
- Sponsor's protocol ID
- TFM3
- Acronym
- TFM3
- Status last verified
- Jul 2019
- First submitted
- 17 May 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04011943
- Acronym / sponsor ID
- TFM3 / TFM3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal Research and Clinical Center of Physical-Chemical MedicineUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.
Detailed description
Objectives of the study:
- To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms.
- To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control.
- Create a bank of fecal samples of healthy donors;
- Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers;
- Analyze the efficacy of therapy with TFM on the sample of patients;
- Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers;
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants with bowel diseases | Experimental | Other: Fecal Microbiota TransplantationTreatment by transplantation of fecal microbiota |
| autologous transplantation of fecal microbiota - healthy | Experimental | Other: Fecal Microbiota TransplantationHealthy volunteers will receive autologous transplantation of fecal microbiota (capsules) |
| Both autologous and heterologous transplantation - healthy | Experimental | Other: Fecal Microbiota TransplantationHealthy volunteers will receive both autologous and heterologous transplantation (capsules) |
| placebo capsules - healthy | Placebo comparator | Other: Fecal Microbiota TransplantationHealthy volunteers will receive placebo capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- the age of patients - from 18 to 75 years, both sexes;
- Patients with:
- Absence of contraindications to gastroscopy
- informed consent of the patient for the transplant procedure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationFecal Microbiota Transplantation | Other | Both autologous and heterologous transplantation - healthy, Participants with bowel diseases, autologous transplantation of fecal microbiota - healthy, placebo capsules - healthy |
Primary outcome
Ulcerative Colitis remission
Time frame: 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
Time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Crohn Disease remission defined as a Harvey-bradshaw index <3.
2 secondary outcomes
Improvement in Ulcerative Colitis symptoms.
Time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Change in gut microbiome
Time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Ilina, MD principal investigator
FRCC PCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation in people with Ulcerative Colitis and Irritable Bowel Syndrome, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcerative Colitis remission (time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.