Table 2.
RCTs of FMT in IBS.
| References | Holster et al. 2019 | Johnson et al. 2018 | Aroniadis et al. 2018 | Halkjaer et al. 2018 | Holvoet et al. 2018 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Country | Sweden | Norway | USA | Denmark | Belgium | ||||||||
| Enrollment period | May 2014–April 2016 | January 2015– October 2015 | 2015–2017 | October 2016 –December 2016 | December 2015 –September 2017 | ||||||||
| Design | Double-blinded RCT | Prospective double-blinded RCT | Randomized double-blinded multi-center crossover trial | Prospective double-blinded RCT | Prospective double-blinded RCT | ||||||||
| Eligible age group (years) | 18–65 | 18–75 | 18–65 | 18–60 | 18–75 | ||||||||
| Total (n) | 16 | 83 | 48 | 51 | 64 | ||||||||
| Jadad Score | 5 | 5 | 4 | 5 | 5 | ||||||||
| Study group | FMT | Control | FMT | Control | FMT followed by control | Placebo followed by FMT | FMT | Placebo | FMT | Control | |||
| Sample size | 8 | 8 | 55 | 28 | 24 | 24 | 25 | 26 | 42 | 22 | |||
| Mean age (years) | 34 | 39 | 44 | 45 | 38.3 ± 12.3 | 38.5 ± 11.8 | 37.28 | 35.54 | NR | NR | |||
| Sex (M:F) | 5:3 | 3:5 | 9:16 | 19:36 | 15:9 | 15:9 | 8:16 | 8:16 | NR | NR | |||
| Years with IBS | Unknown: 0/1–5 years: 4/>5 years: 4 patients | Unknown: 1/1–5 years: 3/>5 years: 4 patients | 10 (6–16) | 10 (5–19) | 8.0 ± 6.0 | 9.0 ± 7.9 | NR | NR | NR | NR | |||
| ROA | Colonoscopy | Colonoscopy | Colonoscopy | Colonoscopy | Oral capsules | Oral capsules | Oral capsules | Oral capsules | Nasojejunal | Nasojejunal | |||
| Follow-up time | 6 months | 6 months | 12 months | 12 months | 12 weeks | 12 weeks | 6 months | 6 months | 12 weeks | 12 weeks | |||
| IBS subtypes | |||||||||||||
| IBS-C, n (%) | 5 (62.5) | 4 (50) | 0 | 0 | 0 | 0 | 7 (28.0) | 10 (38.5) | NR | NR | |||
| IBS-D, n (%) | 1 (12.5) | 3 (37.5) | 24 (44) | 15 (54) | 24 | 24 | 7 (28.0) | 8 (30.8) | NR | NR | |||
| IBS-M, n (%) | 2 (25) | 1 (12.5) | 31 (56) | 13 (46) | 0 | 0 | 11 (44.0) | 8 (30.8) | NR | NR | |||
| Adverse effects, n (%) | 4 (50) | 7 (78.5) | 4 (72.7)a | 3 (10.7) | NR | NR | 22 (84.6) | 15 (57.7) | NR | NR | |||
a
One serious adverse effect (nausea/vertigo needing hospitalization).
RCT: randomized controlled trial; NR: not reported; ROA: route of administration; IBS-C: IBS with constipation; IBD: IBS with diarrhea; IBS-M: mixed IBS.