Rossen 2015.
| Methods | Randomized, double blind trial conducted in the Netherlands | |
| Participants |
The Inclusion criteria Adult patients with UC (N = 48) Established UC according to the Lennard‐Jones criteria, a patient‐reported SCCAI of between 4 and 11 and stable medication, which was continued during the study period Subjects were allowed stable doses of thiopurines, mesalamine, or corticosteroids 10 mg/day for the 8 weeks before inclusion An endoscopic Mayo score of 1 at baseline sigmoidoscopy The exclusion criteria An infectious cause of a UC disease flare A history of colectomy A current stoma A life expectancy of < 12 months Pregnancy Hospital admission Use antibiotics or probiotics within 6 weeks before inclusion. Use of antitumour necrosis factor or methotrexate treatment within 8 weeks before inclusion, or cyclosporine within 4 weeks before inclusion |
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| Interventions |
Study Intervention Stool transplant: Single donor feces; n = 23 Route: Nasoduodenal Frequency: 1 times per 3 weeks, total 2 treatments Weight of stool: 120 g Volume administer per treatment: 500 ml Comparison: Placebo: autologous feces; n = 25 Route: Nasoduodenal Frequency: 1 times per 3 weeks, total 2 treatments Weight of stool: 120 g Volume administer per treatment: 500 ml |
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| Outcomes |
Primary outcome: Combination of clinical remission (defined as a SCCAI score 2) and 1‐point improvement on the combined Mayo endoscopic score of the sigmoid and rectum, as compared with baseline sigmoidoscopy at week 12 Secondary Outcomes: Clinical response (defined as a reduction of 1.5 points on the SCCAI) at week 12 Clinical remission (defined as a SCCAI of 2) at week 12 Endoscopic response at week 12 Change in median IBDQ score at week 12 Adverse events |
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| Notes | Study was stopped early due to futility Multiple donors recruited for study but one patient received feces from one donor only |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from study protocol: "Alea software will be used to perform randomisation" |
| Allocation concealment (selection bias) | Low risk | Quote from study protocol: "Randomisation and preparation of the feces will be performed by one of the research nurses, she is the only person who will know which treatment the patient will be given and will have no role in further part of the study" Comment: Most likely done |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from study protocol: "Patients will be blinded until Follow‐up data until the end of the study (t:12 months) is collected" Comment: Most likely done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from study protocol: "Blinding of participants and trial members was guaranteed by collecting both donor and recipient feces on both treatment days" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall, 25% attrition The dropout rate was similar in both groups. 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 at ClinicalTrials.gov Number: NCT01650038 Study protocol was available for review |
| Other bias | Low risk | Comment: The trial was stopped earlier due to futility; however, the data was completely described for included patients |
UC: ulcerative colitis
FMT: fecal microbiota transplantation
SCCAI: Simple Clinical Colitis Activity Index
IBDQ: Inflammatory Bowel Disease Questionnaire
EQ‐5D: EuroQoL Group Quality of Life Questionnaire
ESR: erythrocyte sedimentation rate
CRP: C‐reactive protein