Clostridium Difficile Infection (CDI)

Antibodies react with C. difficile toxin, C. difficile bacteria and spores; neutralizes the toxin and inhibit the growth of spores and vegetative forms of C. difficile

IM-01

Foothills Medical Center

Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Clinical Effectiveness of Egg-derived Polyclonal Antibodies (IM-01) for the Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Decrease the frequency of unformed bowel motions to less than 3 per day and sustain for the duration of treatment to 10-14 days.

To enumerate numbers of C.difficile present per g of stool by dilution at plate counts on CCFA or Biomerieux C. difficile Chrom Agar , Total counts on three plates express as log 10 count /g versus spore counts after alcohol shock. Toxin titers: expressed as 1/dilution of the fecale filtrate neutralized by specific anti-toxin antibodies from Tech Lab using the CCNA test. .

In those that responded to treatment with resolution of CDI, the rate of recurrence of CDI in a 30, 42 and 56 day follow up period.
• Exploratory outcome: patterns of C. difficile microbial counts and toxin titres in relationship to clinical outcomes from treatment assignments

ImmuniMed Inc.

University of Calgary

University of Manitoba

Twenty four patients in each group will receive IM-01 treatment at 20g or 10g or 5g twice daily:for 10-14 days.

Patients will be randomized 1:1:1 to receive IM-01 treatment dosage at 20g or 10g or 5g twice a day

Consecutive patients admitted as in-patients to the Department of Gastroenterology at four University Hospitals in Denmark, with acute severe UC defined as an affirmed diagnosis of UC according to well established criteria, combined with a Mayo score of 8 or more (i.e. severe disease activity) and the need for intravenous corticosteroid treatment will be screened for participation in the study after informed consent.

Ulcerative Colitis

Ultrasound Therapy; Complications

Standard treatment according to Danish Guidelines for acute severe ulcerative colitis.

Solu-Medrol

Herlev University Hospital

Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.

Number of patients stratified by treatment response (defined by a decrease in clinical Mayo score from baseline ≥ 30 % and ≥ 3 points, along with either a rectal bleeding subscore of 0 or 1 or a decrease in rectal subscore ≥ 1 point) and non-response and their respective change in GIUS parameters (BWT, modified Limberg score, echostratification, inflammatory mesenteric fat and haustration) at 48 ± 24 hours after corticosteroid treatment compared to baseline.

Number of patients stratified after treatment response and non-response after 6 ± 1 days, within 3 months and after 12 months compared to changes in GIUS parameters at each event compared to baseline.

All GIUS scans will be performed by a trained GIUS gastroenterologist and proof read by a second specialist. We wish to examine eventual differences between their assessments.

Although some studies suggest 4 hours of fasting to diminish peristalsis and intraluminal air, fasting before examination is generally not necessary, making it preparation free. We will register patients time since last meal and correlate it to feasibility of GIUS.

Number of correct GIUS assessment of inflammatory extension compared to endoscopy and CT (if present), which is seen as the golden standard, defined by location (rectum, sigmoid colon, descending colon, transverse colon, ascending colon and terminale ileum.

ROC analyses will be performed to determine the best cutoff values for GIUS parameters for optimal sensitivity, specificity and accuracy in predicting treatment outcome (responder vs. non-responder).

Change in GIUS parameters for steroid responders and non-responders and correlation with change in Mayo endoscopic sub-score, UCEIS and fecal calprotectin within 3 months compared to baseline.

Change in GIUS parameters for steroid responders and non-responders and correlation with change in Mayo clinical score, SCCAI, CRP, alpha-1-antitrypsin and increase of albumin or hemoglobin on 48 ± 24 hours, 6 ± 1 days and after 3 months compared to baseline.

Our plan is that fully anonymized data will be accessible from authors upon request.

Johan F. Ilvemark

MD, Principal Investigator

Copenhagen University Hospital at Herlev

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.

Professor Fergus Shanahan

Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork

University College Cork

Surgical Wound Infection

Cystitis

Bacteremia

Pneumonia

Enterocolitis, Pseudomembranous

See protocol - 4 bacteria, 4 fiber mixture

salmonella infections/albumin

Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study

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