Paramsothy 2017a.
| Methods | Randomized, double blind trial conducted in Australia | |
| Participants |
The inclusion Criteria Adult patients aged 18 to 75 years with UC for greater than 3 months (N = 81) Clinically and endoscopically active UC, with a total Mayo score of 4 to 10 and the Mayo endoscopy subscore to be 1 or greater and physician’s global assessment subscore 2 or less. Provide written informed consent to participate as shown by a signature on the consent form Exclusion criteria Consent not obtained or unavailable or inability to communicate with the investigators. Pregnancy, lack of contraception for non‐pregnant women Patient in remission, proctitis < 5 cm, non‐UC IBD, perianal disease, constipation‐predominant UC with < 3 bowel motions/day, mild UC (Mayo score < 4) Severe UC (Mayo score > 10), severe anaemia, leucopenia or granulocytopenia, toxic megacolon Active gastrointestinal infection, Irritable bowel syndrome, diverticulitis, neoplasm etc. Significant gastrointestinal surgery e.g. colon resection, colectomy Medications: antimicrobials (antibiotics, antifungals, antivirals),biologics e.g. infliximab, adalimumab; calcineurin inhibitors; mammalian target of rapamycin inhibitors, chemotherapeutic anti‐neoplastic agents, lymphocyte depleting biological agents; probiotic therapy; experimental drug Steroid dependency: requiring > 20 mg prednisone or > 9 mg budesonide daily Clinical evidence of any major, co‐morbid chronic disease Patients with food hypersensitivity |
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| Interventions |
Study Intervention Donor: Multidonor feces; n = 41 Route: First infusion in terminal Ileum, then colonic enemas Frequency: 5 times per weeks for 8 weeks, total 40 treatments Weight of stool: 37.5 g Volume per treatment: 150 ml Comparison Placebo: Isotonic Saline; n = 40 Route: First infusion in terminal Ileum, then colonic enemas Frequency: 5 times per weeks for 8 weeks, total 40 treatments Volume per treatment: 150 ml |
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| Outcomes |
Primary Outcome: composite of steroid‐free clinical remission at week 8 (defined as a total Mayo score of 2 or less) and endoscopic remission or response which (Mayo subscores of 1 or less, and at least a 1 point reduction from baseline in the endoscopy subscore) Secondary Outcomes Steroid‐free clinical remission at week 8 (defined as combined Mayo subscores of 1 or less for rectal bleeding plus stool frequency) Steroid‐free clinical response (defined as either a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo subscores, or both) Steroid‐free endoscopic response at week 8 (defined as a Mayo endoscopy subscore of 1 or less, with a reduction of at least 1 point from baseline) Steroid‐free endoscopic remission at week 8 (defined as a Mayo endoscopy subscore of 0) Quality of life (assessed with the IBDQ) Adverse events |
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| Notes | Data on quality of life scores was reported as medians and range and was converted to mean and standard deviation by methods given in Hozo 2005 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "using a pre‐established computer‐generated randomisation list with permutated blocks of four and stratified for study site and concomitant corticosteroid use" Comment: Most likely done |
| Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomized centrally by the Centre for Digestive Diseases after screening in a 1:1 ratio" Comment Most likely done |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients and investigators were unaware of treatment allocation" Comment: Most likely done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Study investigators who played a participants’ assessment did not see the investigational product at any time" Comment: Most likely done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall attrition: 24% The dropout rate was similar in both groups and reason for drop outs were given and they were similar in both groups |
| Selective reporting (reporting bias) | Low risk | Comment: The authors seems to report all the a priori outcomes The trial was registered with ClinicalTrials.gov, number NCT01896635 |
| Other bias | Low risk | Comment: No other major risk of bias was noticed |