Inflammatory Bowel DiseasesNCT03787771
The Fecal Microbiota Transplantation Registry
An observational study of Inflammatory Bowel Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 3,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jul 2017to Nov 2046
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: FMT Recipients Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research FMT Donors Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research.
Who may be able to join
- Age ≥ 18
- Written informed consent obtained
- Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research (FMT recipents)
- Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research. Subjects who failed screening will also be recruited. (FMT donors)
Who cannot join
- Age ≤18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Siew Chien Ng, PhD, 852 - 35053996, siewchienng@cuhk.edu.hk
About this study
The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder.
Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies[8]. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A FMT registry is required to explore the relationship between disease prognosis and intestinal microbiota.
Read the detailed description
The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder. A research using gene-sequencing technique showed an abnormal microbiota composition such as specific group of Escherichia coli and decreased diversity of intestinal microbiota in individuals with Inflammatory Bowel Disease (IBD) [2-4]. These microbiotas may stimulate the production of cytokine and chemokines that leads to the mucosal inflammatory activity[5]. Gut microbiota may also link with the development of obesity and diabetes by affecting host fat storage and increasing energy harvest from the diet[6-7].
Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies8. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A recent clinical study evaluated the efficacy of FMT in active Ulcerative Colitis. It showed one-forth cases of the FMT group were in UC remission and an increase in diversity of microbiota composition. However, these results were dependent on the donor[9].
There will be increasing use of FMT in clinical practice, as well as more studies investigating the effectiveness of FMT on other diseases in the future. However, as an emerging procedure, there is currently no registry system to track patient safety information of FMT. It is also equally important to promote scientific investigation around gut microbiome. Therefore, the investigators aim to establish a FMT registry platform to collect clinical data and specimen from FMT recipients and donors. This registry is initiated Hong Kong, and will be expanded to other part of Asia.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Fecal Microbiota Transplantation
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FMT recipents | Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research | |
| FMT donors | Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Set up a FMT registry
Set up a registry of FMT to collect data such as demographics, past medical history, surgery, severity of disease indicated for FMT cases
Measured: 10 years
Secondary outcomes (7)
Patient outcome of FMT
Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey
Measured: 10 years
Factors associated with successful FMT
Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples
Measured: 10 years
Characterize FMT stool donors and other gut-related microbiota products
Collect study samples to characterize which microbiota favors FMT by metagenomics
Measured: 10 years
FMT in Asia
Gather information such as the severity of disease, any adverse event related to FMT and hospitalization from other study sites in Asia. Survey
Measured: 10 years
Promoting scientific investigation in FMT
Collect study samples to characterize which microbiota favors FMT by metagenomics
Measured: 10 years
Future research studies
Number of patients who may be eligible for participation in future research studies by collecting their information demographics, past medical history, surgery, severity of disease
Measured: 10 years
Developing Biobank of FMT
Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start2 Jul 2017
- Primary completionMay 2046 (estimated)
- Study completionNov 2046 (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 Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
- Investigators
- Siew Chien Ng, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787771
- Sponsor's protocol ID
- FMTR
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2018
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yau YK, Lau LHS, Lui RNS, Wong SH, Guo CL, Mak JWY, Ching JYL, Ip M, Kamm MA, Rubin DT, Chan PKS, Chan FKL, Ng SC. Long-Term Safety Outcomes of Fecal Microbiota Transplantation: Real-World Data Over 8 Years From the Hong Kong FMT Registry. Clin Gastroenterol Hepatol. 2024 Mar;22(3):611-620.e12. doi: 10.1016/j.cgh.2023.09.001. Epub 2023 Sep 19.
PubMed 37734581
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fecal Microbiota Transplantation Registry
- ClinicalTrials.gov ID
- NCT03787771
- Acronym / sponsor ID
- FMTR
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Fecal Microbiota Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- May 2046 (estimated)
- Study completion
- Nov 2046 (estimated)
- First posted
- 26 Dec 2018 (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.
The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder.
Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies[8]. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A FMT registry is required to explore the relationship between disease prognosis and intestinal microbiota.
Detailed description
The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder. A research using gene-sequencing technique showed an abnormal microbiota composition such as specific group of Escherichia coli and decreased diversity of intestinal microbiota in individuals with Inflammatory Bowel Disease (IBD) [2-4]. These microbiotas may stimulate the production of cytokine and chemokines that leads to the mucosal inflammatory activity[5]. Gut microbiota may also link with the development of obesity and diabetes by affecting host fat storage and increasing energy harvest from the diet[6-7].
Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies8. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A recent clinical study evaluated the efficacy of FMT in active Ulcerative Colitis. It showed one-forth cases of the FMT group were in UC remission and an increase in diversity of microbiota composition. However, these results were dependent on the donor[9].
There will be increasing use of FMT in clinical practice, as well as more studies investigating the effectiveness of FMT on other diseases in the future. However, as an emerging procedure, there is currently no registry system to track patient safety information of FMT. It is also equally important to promote scientific investigation around gut microbiome. Therefore, the investigators aim to establish a FMT registry platform to collect clinical data and specimen from FMT recipients and donors. This registry is initiated Hong Kong, and will be expanded to other part of Asia.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT recipents | – | –Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research |
| FMT donors | – | –Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- FMT Recipients Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research FMT Donors Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research.
Key inclusion criteria (4 listed)
- Age ≥ 18
- Written informed consent obtained
- Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research (FMT recipents)
- Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research. Subjects who failed screening will also be recruited. (FMT donors)
Key exclusion criteria (1 listed)
- Age ≤18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Set up a FMT registry
Time frame: 10 years
Set up a registry of FMT to collect data such as demographics, past medical history, surgery, severity of disease indicated for FMT cases
7 secondary outcomes
Patient outcome of FMT
Time frame: 10 years
Factors associated with successful FMT
Time frame: 10 years
Characterize FMT stool donors and other gut-related microbiota products
Time frame: 10 years
FMT in Asia
Time frame: 10 years
Promoting scientific investigation in FMT
Time frame: 10 years
Future research studies
Time frame: 10 years
Developing Biobank of FMT
Time frame: 10 years
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 22 Aug 2024.
- Derived from this study: PubMed 37734581Yau YK, Lau LHS, Lui RNS, Wong SH, Guo CL, Mak JWY, Ching JYL, Ip M, Kamm MA, Rubin DT, Chan PKS, Chan FKL, Ng SC. Long-Term Safety Outcomes of Fecal Microbiota Transplantation: Real-World Data Over 8 Years From the Hong Kong FMT Registry. Clin Gastroenterol Hepatol. 2024 Mar;22(3):611-620.e12. doi: 10.1016/j.cgh.2023.09.001. Epub 2023 Sep 19.
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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.
Siew Chien Ng, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 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 22 Aug 2024. 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 Hong Kong. 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. 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?
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 Siew Chien Ng, PhD (852-35053996, siewchienng@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Set up a FMT registry (time frame: 10 years). 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 NCT03787771, 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 22 Aug 2024.