FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Fecal Microbiota Transplantation

• Registration Number: NCT03125564
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-4-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients are aged 18 or above<br><br> - Patients have a diagnosis of IBS consistent with the Rome III criteria (13)<br><br> - Patients did not have adequate relief of global IBS symptoms and of IBS-related<br> bloating at both the time of screening and the time of randomization<br><br> - Patients had undergone clinical investigations with colonoscopy within five years of<br> recruitment<br><br> - Patients with written informed consent form provided<br><br>Exclusion Criteria:<br><br> - Patients have constipation predominant IBS (according to the definition of Rome III<br> criteria)<br><br> - Patients have a history of inflammatory bowel disease or gastrointestinal malignancy<br><br> - Patients have previous abdominal surgery (other than cholecystectomy or<br> appendectomy)<br><br> - Patients have human immunodeficiency virus infection<br><br> - Patients have renal disease manifested by 1.5 times the ULN of serum creatinine or<br> blood urea nitrogen level<br><br> - Patients have hepatic disease manifested by twice the upper limit of normal (ULN)<br> for any of the following liver function tests: alanine aminotransferase, aspartate<br> aminotransferase, alkaline phosphatase, or total bilirubin (except in isolated<br> elevation of unconjugated bilirubin<br><br> - Patients have diabetes mellitus manifested by HbA1C > 6.5%<br><br> - Patients have abnormal thyroid function manifested by values of serum Sensitive<br> Thyroid Stimulating Hormone and serum free T4 fall outside the reference range which<br> is not controlled by thyroid medications<br><br> - Patients have a history of psychiatric illness (mania and schizophrenia)<br><br> - Patients have depression defined by having a Patient Health Questionnaire-9 (PHQ-9)<br> score > 15<br><br> - Patients have anxiety defined by having a Generalized Anxiety Disorder 7 (GAD7)<br> score > 10<br><br> - Patients have active infection at the time of inclusion<br><br> - Patients have used antibiotic therapy or anti-inflammatory drugs within the past 7<br> days<br><br> - Patients have any other organic causes that can explain the symptoms of IBS<br><br> - Current pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the proportion of responders

Secondary Outcome Measures

Name	Time	Method
The proportion of patients who had adequate relief of general IBS symptoms;Assess the onset and duration of relief of general IBS symptoms;The proportion of patients who had improvement on abdominal bloating;Assess the onset and duration of abdominal bloating relief;Assess the Abdominal pain between two groups;Assess the Stool consistency between two groups;Health-related quality of life in patients with irritable bowel syndrome;Assess the level of anxiety between two groups;Assess the change of abdominal pain scores in patients who undergo open-label FMT;The proportion of patients who undergo open-label FMT and have abdominal bloating relief;The IBS quality of life change in patients who undergo open-label FMT;The level of anxiety change in patients who undergo open-label FMT;The changes in diversity and richness of gut microbiota;The changes in gut microbiota at species and functional levels;The similarity of gut microbiota to donors