Table 3. Secondary Binary Outcomes at 6, 12, and 26 Weeks Postintervention.
| Visit, wk | FMT patients | Placebo patients | aOR (95% CI) | P value | |||
|---|---|---|---|---|---|---|---|
| No. | No. (%) | No. | No. (%) | ||||
| Elevated clinic BPa | 0 | 42 | 10 (24) | 45 | 8 (18) | ||
| 6 | 39 | 9 (23) | 44 | 10 (23) | 0.85 (0.27-2.65) | .77 | |
| 12 | 38 | 8 (21) | 41 | 7 (17) | 1.19 (0.35-4.11) | .78 | |
| 26 | 36 | 3 (8) | 41 | 7 (17) | 0.20 (0.03-1.14) | .07 | |
| Abnormal glycaemiaa | 0 | 41 | 22 (54) | 44 | 23 (52) | ||
| 6 | 38 | 20 (53) | 43 | 19 (44) | 1.32 (0.48-3.66) | .59 | |
| 12 | 37 | 21 (57) | 40 | 24 (60) | 0.84 (0.30-2.39) | .75 | |
| 26 | 35 | 24 (69) | 40 | 28 (70) | 0.92 (0.31-2.78) | .88 | |
| Abnormal liver functiona | 0 | 42 | 14 (33) | 45 | 8 (18) | ||
| 6 | 39 | 14 (36) | 43 | 10 (23) | 1.78 (0.65-4.89) | .26 | |
| 12 | 37 | 12 (32) | 40 | 8 (20) | 1.83 (0.63-5.38) | .27 | |
| 26 | 36 | 15 (42) | 40 | 10 (25) | 2.02 (0.73-5.57) | .17 | |
| Dyslipidaemiaa | 0 | 41 | 30 (73) | 45 | 34 (76) | ||
| 6 | 37 | 28 (76) | 43 | 29 (67) | 1.60 (0.56-4.53) | .38 | |
| 12 | 34 | 22 (65) | 40 | 31 (78) | 0.59 (0.20-1.70) | .32 | |
| 26 | 35 | 23 (66) | 40 | 33 (83) | 0.49 (0.16-1.50) | .21 | |
| Metabolic syndromea,b | 0 | 41 | 18 (44) | 45 | 13 (29) | ||
| 6 | 37 | 18 (49) | 43 | 16 (37) | 1.25 (0.43-3.65) | .68 | |
| 12 | 34 | 10 (29) | 40 | 13 (33) | 0.68 (0.21-2.21) | .52 | |
| 26 | 35 | 9 (26) | 40 | 13 (33) | 0.50 (0.15-1.66) | .26 | |
Abbreviations: aOR, adjusted odds ratio; BP; blood pressure; FMT, fecal microbiome transfer.
a
All outcomes defined in eTable 6 in Supplement 3.
b
There was a larger reduction in prevalence of metabolic syndrome with FMT in those who had metabolic syndrome at the start of the study (see eTable 4 in Supplement 3). In the overall analyses, participants from both groups developed metabolic syndrome during the course of the study.