Ulcerative ColitisPhase 2/3NCT03804931
Fecal Microbiota Transplantation for Ulcerative Colitis
A Phase 2/3 study testing Fecal microbiota transplantation, Infusion of Saline and 5-Aminosalicylic acid(5-ASA) and/or Prednisone in people with Ulcerative Colitis and Fecal Microbiota Transplantation, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis, Fecal Microbiota Transplantation
- What is being tested?
- Fecal microbiota transplantation, Infusion of Saline and 5-Aminosalicylic acid(5-ASA) and/or Prednisone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2019to 31 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active, moderate to severe severity (Mayo score more than 6)
- Safety using history of 5-ASA
- Able to undergo endoscopy examination
Who cannot join
- Antibiotic using in 7 days
- High risk of toxic megacolon
- Colon cancer or neoplasia in pathophysiology
- Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong
Hongli Huang, MM, 86-13631316718, honglisums@126.com
Huiting chen, MM, 86-13926055294, gracy1977@tom.com
About this study
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
Read the detailed description
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
- Being tested
- Fecal microbiota transplantation, Infusion of Saline, 5-Aminosalicylic acid(5-ASA) and/or Prednisone
- 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 transplantationProcedure or surgery
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
Infusion of SalineProcedure or surgery
Infusion of Saline
5-Aminosalicylic acid(5-ASA) and/or PrednisoneDrug
Also called Mesalazine, Prednisone
Mesalazine and/or Prednisone
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Fecal microbiota transplantation Receives: Procedure: Fecal microbiota transplantation; Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone |
| placebo fecal microbiota transplantation | Sham comparator | Infusion of Saline Receives: Procedure: Infusion of Saline; Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone |
| Traditional treatments | Other | Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone Receives: Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission in patient as assessed using Mayo score
Total Mayo score less than 2 and no signal item more than 1
Measured: 12 weeks
Clinical improvement in patient as assessed using Mayo score
Total Mayo score decreased more than 3
Measured: 12 weeks
Secondary outcomes (1)
Intestinal microbiota changing
The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start20 Jan 2019 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuqiang Nie, MD, Principal investigator, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804931
- Sponsor's protocol ID
- K-2017-103-01
- Status last verified
- Nov 2018
- First submitted
- 6 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
PubMed 26363929
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03804931
- Acronym / sponsor ID
- K-2017-103-01
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 20 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Jan 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.
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
Detailed description
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Procedure: Fecal microbiota transplantation, Drug: 5-Aminosalicylic acid(5-ASA) and/or PrednisoneFecal microbiota transplantation |
| placebo fecal microbiota transplantation | Sham comparator | Procedure: Infusion of Saline, Drug: 5-Aminosalicylic acid(5-ASA) and/or PrednisoneInfusion of Saline |
| Traditional treatments | Other | Drug: 5-Aminosalicylic acid(5-ASA) and/or PrednisoneDrug:5-Aminosalicylic acid(5-ASA) and/or Prednisone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active, moderate to severe severity (Mayo score more than 6)
- Safety using history of 5-ASA
- Able to undergo endoscopy examination
Key exclusion criteria (4 listed)
- Antibiotic using in 7 days
- High risk of toxic megacolon
- Colon cancer or neoplasia in pathophysiology
- Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)
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 transplantation200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine | Procedure or surgery | Fecal microbiota transplantation |
| Infusion of SalineInfusion of Saline | Procedure or surgery | placebo fecal microbiota transplantation |
| 5-Aminosalicylic acid(5-ASA) and/or PrednisoneAlso: Mesalazine, PrednisoneMesalazine and/or Prednisone | Drug | Fecal microbiota transplantation, Traditional treatments, placebo fecal microbiota transplantation |
Primary outcome
Clinical remission in patient as assessed using Mayo score
Time frame: 12 weeks
Total Mayo score less than 2 and no signal item more than 1
Clinical improvement in patient as assessed using Mayo score
Time frame: 12 weeks
Total Mayo score decreased more than 3
1 secondary outcome
Intestinal microbiota changing
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 26363929Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
Not yet recruiting
Online Pain Education for Crohn's Disease and Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis (UC)
RecruitingObservational study
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Inflammatory Bowel Disease, Ulcerative Colitis
RecruitingPhase 2
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Colitis, Ulcerative
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.
Yuqiang Nie, MD principal investigator
Guangzhou First People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fecal microbiota transplantation, Infusion of Saline and 5-Aminosalicylic acid(5-ASA) and/or Prednisone in people with Ulcerative Colitis and Fecal Microbiota Transplantation, run by Guangzhou First People's Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 15 Jan 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongli Huang, MM (86-13631316718, honglisums@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission in patient as assessed using Mayo score (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT03804931, 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 15 Jan 2019.