Fecal Microbiota TransplantationFMTNCT04706611
Efficacy and Safety of Fecal Microbiota Transplantation
A study testing Fecal Microbiota Transplantation in people with Fecal Microbiota Transplantation, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fecal Microbiota Transplantation
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of any of following diseases:
- Irritable Bowel Syndrome
- Ulcerative colitis
- Crohn's disease
- Constipation
- Clostridium Difficile Infection
Show all 44Show fewer
- Functional Dyspepsia
- Parkinson's Disease
- Metabolic Syndrome
- Non-Alcoholic Fatty Liver Disease
- Autism Spectrum Disorder
- Radiation Enteritis
- Atopic Dermatitis
- Food Allergic
- Graft-versus-Host Disease
- Obesity
- Diabetes mellitus
- Multi-Drug Resistant Infection
- Hepatic Encephalopathy
- Enteric Dysbacteriosis
- Multiple Sclerosis
- Pseudomembranous Enteritis
- Acute Pancreatitis
- Chronic Fatigue Syndrome
- Acute-on-chronic Liver Failure with HBV Infection
- Alcoholic Liver Disease
- Anorexia
- Decompensated Cirrhosis
- Henoch-Schonlein Purpura
- Autoimmune Liver Disease
- Systemic Lupus Erythematosus
- Rheumatoid arthritis
- IgG4-Related Disease
- Celiac Disease
- Protein-losing Enteropathy
- Asperger Syndrome
- Rheumatoid arthritis
- Psoriasis
- Ankylosing spondylitis
- Immune checkpoint inhibition-related colitis
- Autoimmune enteropathy
- Drug-induced diarrhea
- Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc.
- The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.
Who cannot join
- Current pregnancy or breast-feeding;
- Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
- Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
- Any conditions that may render the efficacy of FMT or at the discretion of the investigators.
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, 510180
Yongjian Zhou, MM, 86-13503060150, eyzhouyongjian@scut.edu.cn
Hongli Huang, MM, 86-13631316718, honglisums@126.com
About this study
Official title: Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study
In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.
- Conditions
- Fecal Microbiota Transplantation
- Being tested
- Fecal Microbiota Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationProcedure or surgery
Procedure: Fecal Microbiota Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Irritable Bowel Syndrome | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Constipation | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Clostridium Difficile Infection | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Functional Dyspepsia | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Parkinson's Disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Metabolic Syndrome | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Non-Alcoholic Fatty Liver Disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Autism Spectrum Disorder | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Radiation Enteritis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Atopic Dermatitis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Food Allergic | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Graft-versus-Host Disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Obesity | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Diabetes mellitus | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Multi-Drug Resistant Infection | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Hepatic Encephalopathy | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Enteric Dysbacteriosis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Multiple Sclerosis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Pseudomembranous Enteritis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Acute Pancreatitis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Chronic Fatigue Syndrome | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Acute-on-chronic Liver Failure with HBV Infection | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Alcoholic Liver Disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Anorexia | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Decompensated Cirrhosis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Henoch-Schonlein Purpura | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Autoimmune Liver Disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Systemic Lupus Erythematosus | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| IgG4-Related Disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Celiac Disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Protein-losing Enteropathy | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Asperger Syndrome | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Rheumatoid arthritis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Ulcerative colitis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Crohn's disease | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Psoriasis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Ankylosing spondylitis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Immune checkpoint inhibition-related colitis | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Autoimmune enteropathy | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
| Drug-induced diarrhea | Experimental | Fecal Microbiota Transplantation will be performed. Receives: Procedure: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS).
Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT.
Measured: 1 year
Secondary outcomes (1)
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Fecal Microbiota TransplantationStudies 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongli Huang, MM, Principal investigator, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706611
- Sponsor's protocol ID
- B-2019-041-01
- Acronym
- FMT
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levy M, Kolodziejczyk AA, Thaiss CA, Elinav E. Dysbiosis and the immune system. Nat Rev Immunol. 2017 Apr;17(4):219-232. doi: 10.1038/nri.2017.7. Epub 2017 Mar 6.
PubMed 28260787Brandt LJ. American Journal of Gastroenterology Lecture: Intestinal microbiota and the role of fecal microbiota transplant (FMT) in treatment of C. difficile infection. Am J Gastroenterol. 2013 Feb;108(2):177-85. doi: 10.1038/ajg.2012.450. Epub 2013 Jan 15.
PubMed 23318479Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.
PubMed 28214091Ooijevaar RE, Terveer EM, Verspaget HW, Kuijper EJ, Keller JJ. Clinical Application and Potential of Fecal Microbiota Transplantation. Annu Rev Med. 2019 Jan 27;70:335-351. doi: 10.1146/annurev-med-111717-122956. Epub 2018 Nov 7.
PubMed 30403550Lee P, Yacyshyn BR, Yacyshyn MB. Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT). Diabetes Obes Metab. 2019 Mar;21(3):479-490. doi: 10.1111/dom.13561. Epub 2018 Nov 20.
PubMed 30328245Bajaj JS, Kassam Z, Fagan A, Gavis EA, Liu E, Cox IJ, Kheradman R, Heuman D, Wang J, Gurry T, Williams R, Sikaroodi M, Fuchs M, Alm E, John B, Thacker LR, Riva A, Smith M, Taylor-Robinson SD, Gillevet PM. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Dec;66(6):1727-1738. doi: 10.1002/hep.29306. Epub 2017 Oct 30.
PubMed 28586116Sun MF, Zhu YL, Zhou ZL, Jia XB, Xu YD, Yang Q, Cui C, Shen YQ. Neuroprotective effects of fecal microbiota transplantation on MPTP-induced Parkinson's disease mice: Gut microbiota, glial reaction and TLR4/TNF-alpha signaling pathway. Brain Behav Immun. 2018 May;70:48-60. doi: 10.1016/j.bbi.2018.02.005. Epub 2018 Feb 20.
PubMed 29471030Johnsen PH, Hilpusch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1.
PubMed 29100842El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.
PubMed 31852769Leshem A, Horesh N, Elinav E. Fecal Microbial Transplantation and Its Potential Application in Cardiometabolic Syndrome. Front Immunol. 2019 Jun 14;10:1341. doi: 10.3389/fimmu.2019.01341. eCollection 2019.
PubMed 31258528DeFilipp Z, Bloom PP, Torres Soto M, Mansour MK, Sater MRA, Huntley MH, Turbett S, Chung RT, Chen YB, Hohmann EL. Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant. N Engl J Med. 2019 Nov 21;381(21):2043-2050. doi: 10.1056/NEJMoa1910437. Epub 2019 Oct 30.
PubMed 31665575
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study
- ClinicalTrials.gov ID
- NCT04706611
- Acronym / sponsor ID
- FMT / B-2019-041-01
- Conditions
- Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jan 2021 (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.
In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 40
| Arm | Type | Receives |
|---|---|---|
| Irritable Bowel Syndrome | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Constipation | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Clostridium Difficile Infection | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Functional Dyspepsia | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Parkinson's Disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Metabolic Syndrome | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Non-Alcoholic Fatty Liver Disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Autism Spectrum Disorder | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Radiation Enteritis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Atopic Dermatitis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Food Allergic | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Graft-versus-Host Disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Obesity | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Diabetes mellitus | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Multi-Drug Resistant Infection | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Hepatic Encephalopathy | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Enteric Dysbacteriosis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Multiple Sclerosis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Pseudomembranous Enteritis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Acute Pancreatitis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Chronic Fatigue Syndrome | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Acute-on-chronic Liver Failure with HBV Infection | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Alcoholic Liver Disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Anorexia | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Decompensated Cirrhosis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Henoch-Schonlein Purpura | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Autoimmune Liver Disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Systemic Lupus Erythematosus | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| IgG4-Related Disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Celiac Disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Protein-losing Enteropathy | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Asperger Syndrome | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Rheumatoid arthritis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Ulcerative colitis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Crohn's disease | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Psoriasis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Ankylosing spondylitis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Immune checkpoint inhibition-related colitis | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Autoimmune enteropathy | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
| Drug-induced diarrhea | Experimental | Procedure: Fecal Microbiota TransplantationFecal Microbiota Transplantation will be performed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (44 listed)
- Irritable Bowel Syndrome
- Ulcerative colitis
- Crohn's disease
- Constipation
- Clostridium Difficile Infection
Key exclusion criteria (4 listed)
- Current pregnancy or breast-feeding;
- Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
- Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
- Any conditions that may render the efficacy of FMT or at the discretion of the investigators.
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 TransplantationProcedure: Fecal Microbiota Transplantation | Procedure or surgery | Acute Pancreatitis, Acute-on-chronic Liver Failure with HBV Infection, Alcoholic Liver Disease, Ankylosing spondylitis, Anorexia, Asperger Syndrome, Atopic Dermatitis, Autism Spectrum Disorder, Autoimmune Liver Disease, Autoimmune enteropathy, Celiac Disease, Chronic Fatigue Syndrome, Clostridium Difficile Infection, Constipation, Crohn's disease, Decompensated Cirrhosis, Diabetes mellitus, Drug-induced diarrhea, Enteric Dysbacteriosis, Food Allergic, Functional Dyspepsia, Graft-versus-Host Disease, Henoch-Schonlein Purpura, Hepatic Encephalopathy, IgG4-Related Disease, Immune checkpoint inhibition-related colitis, Irritable Bowel Syndrome, Metabolic Syndrome, Multi-Drug Resistant Infection, Multiple Sclerosis, Non-Alcoholic Fatty Liver Disease, Obesity, Parkinson's Disease, Protein-losing Enteropathy, Pseudomembranous Enteritis, Psoriasis, Radiation Enteritis, Rheumatoid arthritis, Systemic Lupus Erythematosus, Ulcerative colitis |
Primary outcome
The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS).
Time frame: 1 year
Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT.
1 secondary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0
Time frame: 1 year
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 8 Apr 2021.
- Background: PubMed 28260787Levy M, Kolodziejczyk AA, Thaiss CA, Elinav E. Dysbiosis and the immune system. Nat Rev Immunol. 2017 Apr;17(4):219-232. doi: 10.1038/nri.2017.7. Epub 2017 Mar 6.
- Background: PubMed 23318479Brandt LJ. American Journal of Gastroenterology Lecture: Intestinal microbiota and the role of fecal microbiota transplant (FMT) in treatment of C. difficile infection. Am J Gastroenterol. 2013 Feb;108(2):177-85. doi: 10.1038/ajg.2012.450. Epub 2013 Jan 15.
- Background: PubMed 28214091Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.
- Background: PubMed 30403550Ooijevaar RE, Terveer EM, Verspaget HW, Kuijper EJ, Keller JJ. Clinical Application and Potential of Fecal Microbiota Transplantation. Annu Rev Med. 2019 Jan 27;70:335-351. doi: 10.1146/annurev-med-111717-122956. Epub 2018 Nov 7.
- Background: PubMed 30328245Lee P, Yacyshyn BR, Yacyshyn MB. Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT). Diabetes Obes Metab. 2019 Mar;21(3):479-490. doi: 10.1111/dom.13561. Epub 2018 Nov 20.
- Background: PubMed 28586116Bajaj JS, Kassam Z, Fagan A, Gavis EA, Liu E, Cox IJ, Kheradman R, Heuman D, Wang J, Gurry T, Williams R, Sikaroodi M, Fuchs M, Alm E, John B, Thacker LR, Riva A, Smith M, Taylor-Robinson SD, Gillevet PM. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Dec;66(6):1727-1738. doi: 10.1002/hep.29306. Epub 2017 Oct 30.
- Background: PubMed 29471030Sun MF, Zhu YL, Zhou ZL, Jia XB, Xu YD, Yang Q, Cui C, Shen YQ. Neuroprotective effects of fecal microbiota transplantation on MPTP-induced Parkinson's disease mice: Gut microbiota, glial reaction and TLR4/TNF-alpha signaling pathway. Brain Behav Immun. 2018 May;70:48-60. doi: 10.1016/j.bbi.2018.02.005. Epub 2018 Feb 20.
- Background: PubMed 29100842Johnsen PH, Hilpusch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1.
- Background: PubMed 31852769El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.
- Background: PubMed 31258528Leshem A, Horesh N, Elinav E. Fecal Microbial Transplantation and Its Potential Application in Cardiometabolic Syndrome. Front Immunol. 2019 Jun 14;10:1341. doi: 10.3389/fimmu.2019.01341. eCollection 2019.
- Background: PubMed 31665575DeFilipp Z, Bloom PP, Torres Soto M, Mansour MK, Sater MRA, Huntley MH, Turbett S, Chung RT, Chen YB, Hohmann EL. Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant. N Engl J Med. 2019 Nov 21;381(21):2043-2050. doi: 10.1056/NEJMoa1910437. Epub 2019 Oct 30.
- 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.
Hongli Huang, MM 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 study testing Fecal Microbiota Transplantation in people with 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 44 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 8 Apr 2021. 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. 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 Yongjian Zhou, MM (86-13503060150, eyzhouyongjian@scut.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). (time frame: 1 year). 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 NCT04706611, which also lists 11 linked publications.
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 8 Apr 2021.