Ulcerative ColitisPhase 1/2FMTFUCNCT03016780
Fecal Microbiota Transplantation for Ulcerative Colitis
A Phase 1/2 study testing Fecal Microbiota Transplantation and Normal Saline in people with Ulcerative Colitis and Intestinal Bacteria Flora Disturbance, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
Trial summary
Ulcerative colitis is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be related to intestinal flora. 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, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
- What is being tested?
- Fecal Microbiota Transplantation and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2019
- Phase
- Phase 1/2
- 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
- subjects voluntarily participate in the trial and sign informed consent;
- sex is not limited,ranging from 18 to 75 years old;
- meet the diagnostic criteria for ulcerative colitis in patients;
- be able to communicate well with the researchers and follow the verification requirements.
Who cannot join
- Pregnancy or people who are not to give informed consent;
- use of major immunosuppressive agents, including the use of large doses of glucocorticoids, calcineurin inhibitors, mTOR inhibitors, depleted lymphocyte biological agents, anti-tumor necrosis factor and other conditions; chemotherapy of antineoplastic drugs;
- decompensated cirrhosis, progressive AIDS and HIV infectionor other serious immunodeficiency disease;
- use of antibiotics and probiotics within six weeks;
- with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic colon expansion, colon cancer, rectal cancer patients;
- combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
IEC of Chengdu Medical College
Chendu, 610500
Xiaoan Li, Ph.D, +8613680868858, zqzy1983@163.com
About this study
Official title: Evaluation of The Effect of Fecal Microbiota Transplantation on Ulcerative Colitis and Its Mechanism
Ulcerative colitis is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the efficacy of ulcerative colitis by fecal microbiota transplantation needs to be further explored.
Read the detailed description
Patients who meet the inclusion crit ulcerative colitisby will be separated into two parts depending on accepation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal mucosal immunity.
- Conditions
- Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
- Being tested
- Fecal Microbiota Transplantation, Normal Saline
- Keywords
- Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation, Intestinal Mucosal Immunity
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationOther
Also called Fecal Microbiota Transplantation(FMT)
Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.
Normal SalineOther
Also called Normal Saline(NS)
Normal saline and the traditional treatments for ulcerative colitisin in part 2.
| Study group | Role | What they receive |
|---|---|---|
| Treatment in part 1 | Active comparator | Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1. Receives: Other: Fecal Microbiota Transplantation |
| Placebo in part 2 | Placebo comparator | The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
According to the inclusion criteria, the patients were randomly divided into experimental group and control group. Before and after the fecal microbiota transplantation, patients were asked about the history of abdominal pain, abdominal distension, diarrhea and so on,at the same time, monitoring heart rate, respiration, pulse, blood pressure is necessary and determinating liver function, renal function, electrolytes, blood coagulation, blood lipids, endotoxins and other biochemical tests to evaluate clinical efficacy.
Measured: 3 months
Secondary outcomes (3)
Improvement of clinical symptoms of the treatment
We evaluate the improvement of clinical symptoms of the treatment through Clinical Symptom Score of ulcerative colitis and Endoscopic Rachmilewitz Scoreto.
Measured: 4 week
The influence of interleukin-10 after the treatment
Inflammatory factors such as interleukin-10 in the blood of patients with ulcerative colitis and indicators of disease activity such as erythrocyte sedimentation rate, C-reactive protein are often elevated, we want to study the change above indicators before and after treatment, reflecting the improvement of Inflammation of ulcerative colitis and study the effect of its activity.
Measured: 0-4 week
Intestinal mucosal immunity
Ulcerative colitis is an autoimmune disease, it is closely related to the secretory SIgA, and content of serum secretory SIgA of ulcerative colitis patients often decreased. By measuring serum secreted SIgA before and after the treatment of to reflect the immune function of ulcerative colitis.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoan Li, Ph.D, Study chair, First Affiliated Hospital of Chengdu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016780
- Sponsor's protocol ID
- FMT-IBD
- Acronym
- FMTFUC
- Status last verified
- Dec 2016
- First submitted
- 3 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tian Y, Zhou Y, Huang S, Li J, Zhao K, Li X, Wen X, Li XA. Fecal microbiota transplantation for ulcerative colitis: a prospective clinical study. BMC Gastroenterol. 2019 Jul 4;19(1):116. doi: 10.1186/s12876-019-1010-4.
PubMed 31272391
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Fecal Microbiota Transplantation on Ulcerative Colitis and Its Mechanism
- ClinicalTrials.gov ID
- NCT03016780
- Acronym / sponsor ID
- FMTFUC / FMT-IBD
- Conditions
- Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
- Keywords
- Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation, Intestinal Mucosal Immunity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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.
Ulcerative colitis is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the efficacy of ulcerative colitis by fecal microbiota transplantation needs to be further explored.
Detailed description
Patients who meet the inclusion crit ulcerative colitisby will be separated into two parts depending on accepation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal mucosal immunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment in part 1 | Active comparator | Other: Fecal Microbiota TransplantationFecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1. |
| Placebo in part 2 | Placebo comparator | Other: Normal SalineThe traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects voluntarily participate in the trial and sign informed consent;
- sex is not limited,ranging from 18 to 75 years old;
- meet the diagnostic criteria for ulcerative colitis in patients;
- be able to communicate well with the researchers and follow the verification requirements.
Key exclusion criteria (6 listed)
- Pregnancy or people who are not to give informed consent;
- use of major immunosuppressive agents, including the use of large doses of glucocorticoids, calcineurin inhibitors, mTOR inhibitors, depleted lymphocyte biological agents, anti-tumor necrosis factor and other conditions; chemotherapy of antineoplastic drugs;
- decompensated cirrhosis, progressive AIDS and HIV infectionor other serious immunodeficiency disease;
- use of antibiotics and probiotics within six weeks;
- with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic colon expansion, colon cancer, rectal cancer patients;
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 TransplantationAlso: Fecal Microbiota Transplantation(FMT)Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1. | Other | Treatment in part 1 |
| Normal SalineAlso: Normal Saline(NS)Normal saline and the traditional treatments for ulcerative colitisin in part 2. | Other | Placebo in part 2 |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 3 months
According to the inclusion criteria, the patients were randomly divided into experimental group and control group. Before and after the fecal microbiota transplantation, patients were asked about the history of abdominal pain, abdominal distension, diarrhea and so on,at the same time, monitoring heart rate, respiration, pulse, blood pressure is necessary and determinating liver function, renal function, electrolytes, blood coagulation, blood lipids, endotoxins and other biochemical tests to evaluate clinical efficacy.
3 secondary outcomes
Improvement of clinical symptoms of the treatment
Time frame: 4 week
The influence of interleukin-10 after the treatment
Time frame: 0-4 week
Intestinal mucosal immunity
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 31272391Tian Y, Zhou Y, Huang S, Li J, Zhao K, Li X, Wen X, Li XA. Fecal microbiota transplantation for ulcerative colitis: a prospective clinical study. BMC Gastroenterol. 2019 Jul 4;19(1):116. doi: 10.1186/s12876-019-1010-4.
- 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.
Xiaoan Li, Ph.D study chair
First Affiliated Hospital of Chengdu Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Microbiota Transplantation and Normal Saline in people with Ulcerative Colitis and Intestinal Bacteria Flora Disturbance, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
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 4 inclusion and 6 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 11 Jan 2017. 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 China. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xiaoan Li, Ph.D (+8613880868858, zqzy1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03016780, which also lists 1 linked publication.
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 11 Jan 2017.