Summary of findings for the main comparison. Fecal microbiota transplantation compared to control for treatment of ulcerative colitis.
| Fecal microbiota transplantation compared to control for treatment of ulcerative colitis | ||||||
| Patient or population: Participants with active ulcerative colitis inadequately controlled with medication Setting: Outpatient Intervention: Fecal microbiota transplantation via rectal or nasoduodenal routes Comparison: Autologous fecal administration or normal saline placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with Control for Ulcerative Colitis | Risk with Fecal Microbiota Transplantation | |||||
| Clinical remission at 8 weeks | 175 per 1,000 | 356 per 1,000 (187 to 676) | RR 2.03 (1.07 to 3.86) | 277 (4 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | Clinical remission was defined by the included studies ‐ see characteristics of included studies |
| Serious adverse events Follow up: 8‐12 weeks | 51 per 1,000 | 72 per 1,000 (28 to 183) | RR 1.40 (0.55 to 3.58) | 277 (4 RCTs) | ⊕⊕⊝⊝ LOW 3 | Serious adverse events included worsening ulcerative colitis, Clostridium difficile infection, cytomegalovirus infection, small bowel perforation, cervix carcinoma and pneumonia |
| Adverse events Follow‐up: 8 weeks |
754 per 1,000 | 776 per 1,000 (611 to 988) | RR 1.03 (0.81 to 1.31) | 129 (2 RCTs) | ⊕⊕⊕⊝ MODERATE 4 | Common adverse events included abdominal pain, nausea, diarrhea, vomiting, colitis, flatulence, bloating, upper respiratory tract infection, headache, dizziness, fever and transient borborygmus |
| Clinical response at 8 weeks | 277 per 1,000 | 472 per 1,000 (272 to 818) | RR 1.70 (0.98 to 2.95) | 277 (4 RCTs) | ⊕⊕⊝⊝ LOW 5, 6 | Clinical response was defined by the included studies ‐ see characteristics of included studies |
| Endoscopic remission at 8 weeks | 98 per 1,000 | 291 per 1,000 (157 to 538) | RR 2.96 (1.60 to 5.48) | 229 (3 RCTs) | ⊕⊕⊕⊝ MODERATE 7 | Endoscopic remission was defined by the included studies ‐ see characteristics of included studies |
| Clinical relapse at 12 weeks | 200 per 1,000 | 56 per 1,000 (4 to 996) | RR 0.28 (0.02 to 4.98) | 17 (1 RCT) | ⊕⊕⊝⊝ LOW 8 | |
| Endoscopic response at 8 weeks | 200 per 1,000 | 272 per 1,000 (52 to 1,000) | RR 1.36 (0.26 to 7.02) | 129 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 9 10 | Clinical response was defined by the included studies ‐ see characteristics of included studies |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded one level due to serious inconsistency (I² = 50%)
2 Downgraded one level due to serious imprecision (76 events) and wide confidence interval
3 Downgraded two levels due to very serious imprecision (17 events) and wide confidence interval
4 Downgraded one level due to serious imprecision (99 events)
5 Downgraded one level due to serious inconsistency (I² = 64%)
6 Dowgraded one level due to serious imprecision (106 events)
7 Downgraded one level due to serious imprecision (46 events) and wide confidence interval.
8 Downgraded two levels due to very serious imprecision (2 events) and very wide confidence interval
9 Downgraded two levels due to very serious inconsistency (I² = 82%)
10 Downgraded one level due to serious imprecision (31 events) and wide confidence interval