FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment
FMT for Patients With IBS 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.
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.
Inclusion Criteria:

 -  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 two years of
 recruitment

 -  Patients with written informed consent form provided

 Exclusion Criteria:

 -  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

 -  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