FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment

Launched by CHINESE UNIVERSITY OF HONG KONG · Apr 19, 2017

Keywords

ClinConnect 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 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. ...

Gender

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Eligibility criteria

• 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 five 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