The treatment group will have faecal microbiota transplantation performed using stool from a healthy human donor

The placebo group will have autologous faecal microbiota transplantation performed.

Irritable Bowel Syndrome

Faecal microbiota transplantation

Alimentary Pharmabiotic Centre, University College Cork

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Irritable Bowel Syndrome

This assessment will be obtained by defining the response (Yes or No) to the following question.
"Please consider how you felt in the past week in regard to your IBS, in particular your overall well-being, and symptoms of abdominal discomfort or pain, bloating or distension and altered bowel habit .Compared to the way you usually felt before the beginning of the trial, have you had adequate relief of your IBS-symptoms?"

The primary symptoms of IBS will be scored on a six point Likert scale at baseline, week 4 and at end of study. The following symptoms will be assessed and recorded: abdominal pain/discomfort, bloating/distension, sense of incomplete evacuation, straining at stool, urgency of bowel movement, passage of gas and mucus, bowel habit satisfaction. Each symptom will be assessed using a 6-point scale, where 0 = none to 5 = very severe. Bowel habit satisfaction will be assessed using a 6-point scale where 0 = very satisfied and 5 = very dissatisfied. Overall assessment of IBS symptoms will be also be scored on a 6 - point scale. An IBS composite score(15 point score) representing the sum of individual scores for abdominal pain/discomfort, bloating/distension, and bowel movement difficulty (straining at stool or urgency of bowel movement) will be calculated.

At baseline and at the end of the study each subject will complete an IBS-specific quality of life questionnaire (IBS-QOL)

At baseline and at the end of the study each subject will complete the Hospital Anxiety and Depression (HAD) Scale.

Patients will be monitored throughout the study period and they will be recorded as per the The Consolidated Standards of Reporting Trials (CONSORT) criteria

We will characterise all participants' microbiota composition at baseline and at the end of study to determine if there is a subgroup of patient/donor combinations, based on their microbiota composition, in whom a positive response to FMT was obtained. This would be very valuable for future optimization of a positive primary outcome.

hepatitis a/albumiin

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

A Randomized Controlled Trial of Lamivudine in Acute Hepatitis B

Kõige täiuslikum ravimtaimede andmebaas, mida toetab teadus