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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation | Experimental | FMT infusion and Fecal and Mucosal Microbiota Assessment |
|
| Sham infusion | Sham Comparator | Infusion with sham and Fecal and Mucosal Microbiota Assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Procedure | Fecal microbiota transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of responders | Response means a symptom relief of more than 50 points assessed by IBS-SSS. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who had adequate relief of general IBS symptoms | Adequate relief of general IBS symptoms | 12 weeks |
| Assess the onset and duration of relief of general IBS symptoms | The onset and duration of relief of general IBS symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siew Ng, Prof. | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Shatin | 000000 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15239910 | Background | 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. | |
| 12241674 | Background | Talley 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. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| C005703 | salicylhydroxamic acid |
| D003672 | Defecation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| Sham | Procedure | Infusion of sham |
|
| Fecal and Mucosal Microbiota Assessment | Procedure | To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation |
|
| 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. | 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. | 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 | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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 | 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 | 12 weeks |
| The similarity of gut microbiota to donors | Assessing the similarity of gut microbiota to donors in patients following FMT | 12 weeks |
| 24751910 | Background | Collins 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. |
| 17631127 | Background | Kassinen 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. |
| 23800182 | Background | Ng 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. |
| 8544549 | Background | Gwee 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. |
| 16319671 | Background | Spiller 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. |
| 20236566 | Background | Parkes 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. |
| 21208106 | Background | Pimentel 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. |
| 23718168 | Background | van 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. |
| 37667968 | Derived | Yau 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. |
| D004066 | Digestive System Diseases |