Irritable Bowel SyndromeNCT03125564
FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment
A study testing Fecal Microbiota Transplantation and Fecal and Mucosal Microbiota Assessment in people with Irritable Bowel Syndrome and Fecal Microbiota Transplantation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Fecal Microbiota Transplantation
- What is being tested?
- Fecal Microbiota Transplantation and Fecal and Mucosal Microbiota Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Apr 2017to 16 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are aged 18 or above
- Patients have a diagnosis of IBS consistent with the Rome III criteria (13)
- Patients did not have adequate relief of global IBS symptoms and of IBS-related bloating at both the time of screening and the time of randomization
- Patients had undergone clinical investigations with colonoscopy within five years of recruitment
- Patients with written informed consent form provided
Who cannot join
- Patients have constipation predominant IBS (according to the definition of Rome III criteria)
- Patients have a history of inflammatory bowel disease or gastrointestinal malignancy
- Patients have previous abdominal surgery (other than cholecystectomy or appendectomy)
- Patients have human immunodeficiency virus infection
- Patients have renal disease manifested by 1.5 times the ULN of serum creatinine or blood urea nitrogen level
- Patients have hepatic disease manifested by twice the upper limit of normal (ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin
Show all 15Show fewer
- Patients have diabetes mellitus manifested by HbA1C > 6.5%
- Patients have abnormal thyroid function manifested by values of serum Sensitive Thyroid Stimulating Hormone and serum free T4 fall outside the reference range which is not controlled by thyroid medications
- Patients have a history of psychiatric illness (mania and schizophrenia)
- Patients have depression defined by having a Patient Health Questionnaire-9 (PHQ-9) score > 15
- Patients have anxiety defined by having a Generalized Anxiety Disorder 7 (GAD7) score > 10
- Patients have active infection at the time of inclusion
- Patients have used antibiotic therapy or anti-inflammatory drugs within the past 7 days
- Patients have any other organic causes that can explain the symptoms of IBS
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-controlled Study on Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome With Fecal and Mucosal Microbiota Assessment
Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections. The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Until recently, the development of an effective therapy for this condition has been hampered by a poor understanding of the etiology of the disease. Traditionally the underlying pathogenesis of IBS has been centered on the brain-gut axis whereby stress and psychological conditions alter the perception of IBS symptoms. Emerging evidence however supports the observation that at least in a subgroup of patients with IBS, peripheral mechanisms within the intestine including low grade mucosal inflammation, abnormal immune activation and altered visceral sensitivity may be the main drivers of the manifestations in IBS.
Accumulating data suggest that the intestinal microbiota play an important role in the pathophysiology of IBS. This is derived from early observation that post-infectious IBS developed in a subgroup of patients following a bout of gastroenteritis. Several studies have shown that the fecal microbiota was altered in IBS and IBS symptoms can be improved by therapeutic interventions that target the microbiota including antibiotics, probiotics and prebiotics. Rifaximin, an oral, non-systemic broad spectrum antibiotics has also been shown to provide significant relief in IBS symptoms in a randomized controlled trial.
Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections.The mechanism of FMT in IBS is not completely clear.
The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.
- Being tested
- Fecal Microbiota Transplantation, Sham, Fecal and Mucosal Microbiota Assessment
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationProcedure or surgery
Fecal microbiota transplantation
ShamProcedure or surgery
Infusion of sham
Fecal and Mucosal Microbiota AssessmentProcedure or surgery
To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | FMT infusion and Fecal and Mucosal Microbiota Assessment Receives: Procedure: Fecal Microbiota Transplantation; Procedure: Fecal and Mucosal Microbiota Assessment |
| Sham infusion | Sham comparator | Infusion with sham and Fecal and Mucosal Microbiota Assessment Receives: Procedure: Sham; Procedure: Fecal and Mucosal Microbiota Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of responders
Response means a symptom relief of more than 50 points assessed by IBS-SSS.
Measured: 12 weeks
Secondary outcomes (15)
The proportion of patients who had adequate relief of general IBS symptoms
Adequate relief of general IBS symptoms
Measured: 12 weeks
Assess the onset and duration of relief of general IBS symptoms
The onset and duration of relief of general IBS symptoms
Measured: 12 weeks
The proportion of patients who had improvement on abdominal bloating
Proportion of patients who had improvement on abdominal bloating between the treatment arms.
Measured: 12 weeks
Assess the onset and duration of abdominal bloating relief
The onset and duration of abdominal bloating relief were assessed by phone interview and follow-up visits.
Measured: 12 weeks
Assess the Abdominal pain between two groups
Assess abdominal pain by symptoms diary between treatment and placebo arms. The symptoms diary assesses abdominal pain on a scale of 0-10 and higher scores mean severe abdominal pain
Measured: 12 weeks
Assess the Stool consistency between two groups
Assess stool consistency by Bristol Stool Scale between treatment and placebo arms. The Bristol Stool Scale ranges from 1 to 7.
Measured: 12 weeks
Health-related quality of life in patients with irritable bowel syndrome
Assess quality of life by Irritable Bowel Syndrome Quality of Life (IBS-QOL) scale between treatment and placebo arms. The IBS-QOL scale ranges from 0 to 100 scores with higher scores indicating better quality of life.
Measured: 12 weeks
Assess the level of anxiety between two groups
Assess the Anxiety scale by General Anxiety Disorder-7 (GAD-7) between treatment and placebo arms. The total scores of GAD-7 range from 0 to 21 with higher scores indicating more severe level of anxiety.
Measured: 12 weeks
Assess the change of abdominal pain scores in patients who undergo open-label FMT
After unblinding, patients in the placebo group will be given a choice to receive open-label FMT and follow up under the same schedule as the blinded phase. The abdominal pain scores will be assessed by symptoms diary on a scale of 0-10 and higher scores mean severe abdominal pain
Measured: 12 weeks
The proportion of patients who undergo open-label FMT and have abdominal bloating relief
After unblinding, patients in the placebo group will be given a choice to receive open-label FMT and follow up under the same schedule as the blinded phase. The abdominal bloating relief was assessed by phone interview and follow-up visits.
Measured: 12 weeks
The IBS quality of life change in patients who undergo open-label FMT
After unblinding, patients in the placebo group will be given a choice to receive open-label FMT and follow up under the same schedule as the blinded phase. Quality of life was assessed by Irritable Bowel Syndrome Quality of Life (IBS-QOL) scale which ranges from 0 to 100 scores with higher scores indicating better quality of life.
Measured: 12 weeks
The level of anxiety change in patients who undergo open-label FMT
After unblinding, patients in the placebo group will be given a choice to receive open-label FMT and follow up under the same schedule as the blinded phase. Anxiety was assessed by General Anxiety Disorder-7 (GAD-7). The total scores of GAD-7 range from 0 to 21 with higher scores indicating more severe level of anxiety.
Measured: 12 weeks
The changes in diversity and richness of gut microbiota
Evaluating the changes in the diversity (shannon index) and richness (number of observed species) of gut microbiota of patients receiving FMT or placebo
Measured: 12 weeks
The changes in gut microbiota at species and functional levels
Assessing changes in gut microbiota at species and functional levels in patients receiving FMT or placebo
Measured: 12 weeks
The similarity of gut microbiota to donors
Assessing the similarity of gut microbiota to donors in patients following FMT
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 posted24 Apr 2017
- Study start12 Apr 2017
- Primary completion16 Sep 2022
- Study completion16 Dec 2023
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 Irritable Bowel SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
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 Ng, Prof., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125564
- Sponsor's protocol ID
- FMT-IBS study
- Status last verified
- Aug 2024
- First submitted
- 7 Apr 2017
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson S, Roberts L, Roalfe A, Bridge P, Singh S. Prevalence of irritable bowel syndrome: a community survey. Br J Gen Pract. 2004 Jul;54(504):495-502.
PubMed 15239910Talley NJ, Spiller R. Irritable bowel syndrome: a little understood organic bowel disease? Lancet. 2002 Aug 17;360(9332):555-64. doi: 10.1016/S0140-6736(02)09712-X.
PubMed 12241674Collins SM. A role for the gut microbiota in IBS. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):497-505. doi: 10.1038/nrgastro.2014.40. Epub 2014 Apr 22.
PubMed 24751910Kassinen A, Krogius-Kurikka L, Makivuokko H, Rinttila T, Paulin L, Corander J, Malinen E, Apajalahti J, Palva A. The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subjects. Gastroenterology. 2007 Jul;133(1):24-33. doi: 10.1053/j.gastro.2007.04.005. Epub 2007 Apr 14.
PubMed 17631127Ng SC, Lam EF, Lam TT, Chan Y, Law W, Tse PC, Kamm MA, Sung JJ, Chan FK, Wu JC. Effect of probiotic bacteria on the intestinal microbiota in irritable bowel syndrome. J Gastroenterol Hepatol. 2013 Oct;28(10):1624-31. doi: 10.1111/jgh.12306.
PubMed 23800182Gwee KA, Graham JC, McKendrick MW, Collins SM, Marshall JS, Walters SJ, Read NW. Psychometric scores and persistence of irritable bowel after infectious diarrhoea. Lancet. 1996 Jan 20;347(8995):150-3. doi: 10.1016/s0140-6736(96)90341-4.
PubMed 8544549Spiller R, Campbell E. Post-infectious irritable bowel syndrome. Curr Opin Gastroenterol. 2006 Jan;22(1):13-7. doi: 10.1097/01.mog.0000194792.36466.5c.
PubMed 16319671Parkes GC, Sanderson JD, Whelan K. Treating irritable bowel syndrome with probiotics: the evidence. Proc Nutr Soc. 2010 May;69(2):187-94. doi: 10.1017/S002966511000011X. Epub 2010 Mar 18.
PubMed 20236566Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.
PubMed 21208106van Nood E, Dijkgraaf MG, Keller JJ. Duodenal infusion of feces for recurrent Clostridium difficile. N Engl J Med. 2013 May 30;368(22):2145. doi: 10.1056/NEJMc1303919. No abstract available.
PubMed 23718168Yau YK, Su Q, Xu Z, Tang W, Ching JYL, Mak JWY, Cheung CP, Fung M, Ip M, Chan PKS, Wu JCY, Chan FKL, Ng SC. Randomised clinical trial: Faecal microbiota transplantation for irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Oct;58(8):795-804. doi: 10.1111/apt.17703. Epub 2023 Sep 5.
PubMed 37667968
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
- A Randomised, Placebo-controlled Study on Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome With Fecal and Mucosal Microbiota Assessment
- ClinicalTrials.gov ID
- NCT03125564
- Acronym / sponsor ID
- FMT-IBS study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 24 Apr 2017 (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.
Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections. The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.
Detailed description
Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Until recently, the development of an effective therapy for this condition has been hampered by a poor understanding of the etiology of the disease. Traditionally the underlying pathogenesis of IBS has been centered on the brain-gut axis whereby stress and psychological conditions alter the perception of IBS symptoms. Emerging evidence however supports the observation that at least in a subgroup of patients with IBS, peripheral mechanisms within the intestine including low grade mucosal inflammation, abnormal immune activation and altered visceral sensitivity may be the main drivers of the manifestations in IBS.
Accumulating data suggest that the intestinal microbiota play an important role in the pathophysiology of IBS. This is derived from early observation that post-infectious IBS developed in a subgroup of patients following a bout of gastroenteritis. Several studies have shown that the fecal microbiota was altered in IBS and IBS symptoms can be improved by therapeutic interventions that target the microbiota including antibiotics, probiotics and prebiotics. Rifaximin, an oral, non-systemic broad spectrum antibiotics has also been shown to provide significant relief in IBS symptoms in a randomized controlled trial.
Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections.The mechanism of FMT in IBS is not completely clear.
The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Procedure: Fecal Microbiota Transplantation, Procedure: Fecal and Mucosal Microbiota AssessmentFMT infusion and Fecal and Mucosal Microbiota Assessment |
| Sham infusion | Sham comparator | Procedure: Sham, Procedure: Fecal and Mucosal Microbiota AssessmentInfusion with sham and Fecal and Mucosal Microbiota Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are aged 18 or above
- Patients have a diagnosis of IBS consistent with the Rome III criteria (13)
- Patients did not have adequate relief of global IBS symptoms and of IBS-related bloating at both the time of screening and the time of randomization
- Patients had undergone clinical investigations with colonoscopy within five years of recruitment
- Patients with written informed consent form provided
Key exclusion criteria (15 listed)
- Patients have constipation predominant IBS (according to the definition of Rome III criteria)
- Patients have a history of inflammatory bowel disease or gastrointestinal malignancy
- Patients have previous abdominal surgery (other than cholecystectomy or appendectomy)
- Patients have human immunodeficiency virus infection
- Patients have renal disease manifested by 1.5 times the ULN of serum creatinine or blood urea nitrogen level
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 | Procedure or surgery | Fecal Microbiota Transplantation |
| ShamInfusion of sham | Procedure or surgery | Sham infusion |
| Fecal and Mucosal Microbiota AssessmentTo assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation | Procedure or surgery | Fecal Microbiota Transplantation, Sham infusion |
Primary outcome
the proportion of responders
Time frame: 12 weeks
Response means a symptom relief of more than 50 points assessed by IBS-SSS.
15 secondary outcomes
The proportion of patients who had adequate relief of general IBS symptoms
Time frame: 12 weeks
Assess the onset and duration of relief of general IBS symptoms
Time frame: 12 weeks
The proportion of patients who had improvement on abdominal bloating
Time frame: 12 weeks
Assess the onset and duration of abdominal bloating relief
Time frame: 12 weeks
Assess the Abdominal pain between two groups
Time frame: 12 weeks
Assess the Stool consistency between two groups
Time frame: 12 weeks
Health-related quality of life in patients with irritable bowel syndrome
Time frame: 12 weeks
Assess the level of anxiety between two groups
Time frame: 12 weeks
Assess the change of abdominal pain scores in patients who undergo open-label FMT
Time frame: 12 weeks
The proportion of patients who undergo open-label FMT and have abdominal bloating relief
Time frame: 12 weeks
The IBS quality of life change in patients who undergo open-label FMT
Time frame: 12 weeks
The level of anxiety change in patients who undergo open-label FMT
Time frame: 12 weeks
The changes in diversity and richness of gut microbiota
Time frame: 12 weeks
The changes in gut microbiota at species and functional levels
Time frame: 12 weeks
The similarity of gut microbiota to donors
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 15239910Wilson S, Roberts L, Roalfe A, Bridge P, Singh S. Prevalence of irritable bowel syndrome: a community survey. Br J Gen Pract. 2004 Jul;54(504):495-502.
- Background: PubMed 12241674Talley NJ, Spiller R. Irritable bowel syndrome: a little understood organic bowel disease? Lancet. 2002 Aug 17;360(9332):555-64. doi: 10.1016/S0140-6736(02)09712-X.
- Background: PubMed 24751910Collins SM. A role for the gut microbiota in IBS. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):497-505. doi: 10.1038/nrgastro.2014.40. Epub 2014 Apr 22.
- Background: PubMed 17631127Kassinen A, Krogius-Kurikka L, Makivuokko H, Rinttila T, Paulin L, Corander J, Malinen E, Apajalahti J, Palva A. The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subjects. Gastroenterology. 2007 Jul;133(1):24-33. doi: 10.1053/j.gastro.2007.04.005. Epub 2007 Apr 14.
- Background: PubMed 23800182Ng SC, Lam EF, Lam TT, Chan Y, Law W, Tse PC, Kamm MA, Sung JJ, Chan FK, Wu JC. Effect of probiotic bacteria on the intestinal microbiota in irritable bowel syndrome. J Gastroenterol Hepatol. 2013 Oct;28(10):1624-31. doi: 10.1111/jgh.12306.
- Background: PubMed 8544549Gwee KA, Graham JC, McKendrick MW, Collins SM, Marshall JS, Walters SJ, Read NW. Psychometric scores and persistence of irritable bowel after infectious diarrhoea. Lancet. 1996 Jan 20;347(8995):150-3. doi: 10.1016/s0140-6736(96)90341-4.
- Background: PubMed 16319671Spiller R, Campbell E. Post-infectious irritable bowel syndrome. Curr Opin Gastroenterol. 2006 Jan;22(1):13-7. doi: 10.1097/01.mog.0000194792.36466.5c.
- Background: PubMed 20236566Parkes GC, Sanderson JD, Whelan K. Treating irritable bowel syndrome with probiotics: the evidence. Proc Nutr Soc. 2010 May;69(2):187-94. doi: 10.1017/S002966511000011X. Epub 2010 Mar 18.
- Background: PubMed 21208106Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.
- Background: PubMed 23718168van Nood E, Dijkgraaf MG, Keller JJ. Duodenal infusion of feces for recurrent Clostridium difficile. N Engl J Med. 2013 May 30;368(22):2145. doi: 10.1056/NEJMc1303919. No abstract available.
- Derived from this study: PubMed 37667968Yau YK, Su Q, Xu Z, Tang W, Ching JYL, Mak JWY, Cheung CP, Fung M, Ip M, Chan PKS, Wu JCY, Chan FKL, Ng SC. Randomised clinical trial: Faecal microbiota transplantation for irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Oct;58(8):795-804. doi: 10.1111/apt.17703. Epub 2023 Sep 5.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Siew Ng, Prof. 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?
A study testing Fecal Microbiota Transplantation and Fecal and Mucosal Microbiota Assessment in people with Irritable Bowel Syndrome and Fecal Microbiota Transplantation, 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 5 inclusion and 15 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: finished, 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the proportion of responders (time frame: 12 weeks). 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 NCT03125564, 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 22 Aug 2024.