Table 2.
Outcome measures comparing FMT with placebo.
| Outcome | Estimates and standard errors |
Adjusted mean difference (95% CI) | P value | |
|---|---|---|---|---|
| Placebo group (n = 34) | FMT group (n = 34) | |||
| Primary outcome | ||||
| Mean change from baseline to week 16 | ||||
| PSPRS total score | 1.7 (0.3) | −2.6 (0.5) | 4.3 (3.2, 5.4) | <0.0001 |
| Secondary outcomes | ||||
| Mean change from baseline to week 2 | ||||
| PSPRS total score | 0.2 (0.3) | −1.5 (0.5) | 1.7 (0.6, 2.8) | 0.0046 |
| PSPRS-V+VI | 0.0 (0.1) | −0.6 (0.2) | 0.6 (0.2, 1.1) | 0.0079 |
| GSRS | −1.2 (0.4) | −1.3 (0.4) | 0.1 (−1.1, 1.2) | 0.89 |
| CSS | −1.0 (0.4) | −2.5 (0.7) | 1.5 (0.0, 3.1) | 0.067 |
| UPDRS II | −0.1 (0.3) | −0.5 (0.4) | 0.4 (−0.5, 1.3) | 0.37 |
| PAC-QoL | −3.5 (2.2) | −12.9 (2.5) | 9.4 (4.3, 14.4) | 0.0005 |
| RBDQ-HK | −0.1 (0.2) | 0.1 (0.2) | −0.1 (−0.7, 0.5) | 0.67 |
| MMSE | 0.0 (0.2) | 0.0 (0.2) | 0.0 (−0.5, 0.6) | 0.96 |
| HAMD | 0.3 (0.7) | −1.9 (0.7) | 2.3 (0.6, 3.9) | 0.0083 |
| HAMA | −0.5 (0.8) | −2.5 (0.8) | 2.0 (0.1, 3.9) | 0.045 |
| SEADL | 0.0 (0.4) | 0.0 (0.6) | 0.0 (−1.4, 1.4) | 1.0 |
| Mean change from baseline to week 7 | ||||
| PSPRS total score | 0.3 (0.3) | −2.5 (0.5) | 2.8 (1.7, 3.9) | <0.0001 |
| PSPRS-V+VI | 0.1 (0.1) | −1.4 (0.2) | 1.5 (1.0, 1.9) | <0.0001 |
| GSRS | −1.5 (0.4) | −2.4 (0.4) | 0.9 (−0.3, 2.0) | 0.15 |
| CSS | −1.3 (0.4) | −3.4 (0.7) | 2.2 (0.6, 3.8) | 0.011 |
| UPDRS II | 0.0 (0.3) | −1.4 (0.4) | 1.4 (0.5, 2.3) | 0.0026 |
| PAC-QoL | −4.5 (2.3) | −15.3 (2.6) | 10.9 (5.8, 16.0) | 0.0001 |
| RBDQ-HK | −0.2 (0.2) | 0.1 (0.2) | −0.2 (−0.8, 0.3) | 0.42 |
| MMSE | 0.0 (0.2) | −0.1 (0.2) | 0.2 (−0.4, 0.7) | 0.58 |
| HAMD | 1.1 (0.6) | −2.3 (0.7) | 3.4 (1.7, 5.1) | 0.0001 |
| HAMA | −0.4 (0.8) | −3.2 (0.8) | 2.8 (0.9, 4.8) | 0.0051 |
| SEADL | 0.0 (0.4) | 0.0 (0.6) | 0.0 (−1.4, 1.4) | 1.0 |
| Mean change from baseline to week 12 | ||||
| PSPRS total score | 0.6 (0.3) | −4.2 (0.5) | 4.8 (3.7, 5.9) | <0.0001 |
| PSPRS-V+VI | 0.2 (0.1) | −2.4 (0.2) | 2.6 (2.2, 3.1) | <0.0001 |
| GSRS | −2.0 (0.4) | −2.8 (0.4) | 0.8 (−0.3, 2.0) | 0.16 |
| CSS | −2.0 (0.4) | −4.6 (0.7) | 2.6 (1.0, 4.1) | 0.0033 |
| UPDRS II | 0.1 (0.3) | −2.5 (0.4) | 2.6 (1.7, 3.5) | <0.0001 |
| PAC-QoL | −4.5 (2.6) | −18.7 (2.9) | 14.1 (9.0, 19.2) | <0.0001 |
| RBDQ-HK | −0.2 (0.2) | 0.1 (0.2) | −0.3 (−0.9, 0.3) | 0.31 |
| MMSE | 0.0 (0.2) | −0.7 (0.2) | 0.6 (0.1, 1.2) | 0.024 |
| HAMD | 1.0 (0.7) | −2.4 (0.7) | 3.5 (1.8, 5.1) | 0.0001 |
| HAMA | −0.2 (0.9) | −3.3 (0.9) | 3.1 (0.9, 4.8) | 0.0022 |
| SEADL | 0.0 (0.4) | 1.2 (0.6) | −2.1 (−2.5, 0.2) | 0.095 |
| Mean change from baseline to week 16 | ||||
| PSPRS-V+VI | 0.6 (0.1) | −1.6 (0.2) | 2.3 (1.8, 2.7) | <0.0001 |
| GSRS | 0.1 (0.4) | −2.8 (0.4) | 2.9 (1.8, 4.1) | <0.0001 |
| CSS | −0.3 (0.4) | −2.7 (0.7) | 2.5 (0.9, 4.0) | 0.0049 |
| UPDRS II | 1.5 (0.3) | −2.2 (0.4) | 3.7 (2.8, 4.6) | <0.0001 |
| PAC-QoL | −0.8 (2.4) | −13.1 (2.7) | 12.4 (7.3, 17.5) | <0.0001 |
| RBDQ-HK | 0.4 (0.2) | 0.7 (0.2) | −0.3 (−0.9, 0.3) | 0.32 |
| MMSE | −0.7 (0.2) | −1.6 (0.2) | 1.0 (0.4, 1.6) | 0.0007 |
| HAMD | 3.1 (0.7) | −0.8 (0.7) | 3.9 (2.2, 5.6) | <0.0001 |
| HAMA | 2.1 (0.9) | −1.6 (0.9) | 3.7 (1.7, 5.7) | 0.0003 |
| SEADL | 0.6 (0.4) | 1.8 (0.6) | −1.2 (−2.5, 0.2) | 0.095 |
| Mean change from baseline to week 36 | ||||
| PSPRS total score | 5.4 (0.3) | 1.5 (0.5) | 3.8 (2.7, 4.9) | <0.0001 |
| PSPRS-V+VI | 2.7 (0.1) | 0.8 (0.2) | 1.9 (1.4, 2.3) | <0.0001 |
| GSRS | 2.3 (0.4) | −0.3 (0.4) | 2.6 (1.4, 3.7) | 0.0001 |
| CSS | 0.9 (0.4) | −0.2 (0.6) | 1.0 (−0.5, 2.6) | 0.20 |
| UPDRS II | −4.2 (0.3) | 1.0 (0.4) | 3.2 (2.4, 4.1) | <0.0001 |
| PAC-QoL | 4.3 (2.6) | −4.1 (2.9) | 8.5 (3.3, 13.6) | 0.0016 |
| RBDQ-HK | 2.3 (0.2) | 1.5 (0.2) | 0.8 (0.3, 1.4) | 0.0051 |
| MMSE | −1.6 (0.2) | −2.4 (0.2) | 0.8 (0.3, 1.4) | 0.0040 |
| HAMD | 4.3 (0.7) | 0.6 (0.7) | 3.7 (2.0, 5.4) | <0.0001 |
| HAMA | 3.9 (0.8) | 0.2 (0.8) | 3.7 (1.8, 5.7) | 0.0003 |
| SEADL | −0.3 (0.4) | −1.1 (0.6) | 0.9 (−0.5, 2.2) | 0.21 |
Note: α1-AT, alpha-1-antitrypsin; BMI, Body-mass index; CALP, calprotectin; CI, confidence interval; CSS, Constipation Scoring System; FMT, faecal microbiota transplantation; GSRS, Gastrointestinal Symptom Rating Scale; HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale; LF, lactoferrin; MMSE, Mini-Mental State Examination; MoCA, Montreal Cognitive Assessment; PAC-QoL, Patient Assessment of Constipation Quality of Life; PSP-RS, progressive supranuclear palsy–Richardson's syndrome; PSPRS, Progressive Supranuclear Palsy Rating Scale; RBDQ-HK, REM sleep behavior disorder questionnaire-Hong Kong; SEADL, Schwab and England Activities of Daily Living; UPDRS, Unified Parkinson's Disease Rating Scale. The primary and secondary outcomes between treatment groups were assessed on an intention-to-treat basis using a mixed-model, repeated-measures analysis with fixed effects of treatment group, time (categorical), treatment group by time interaction, baseline value, and baseline value by time interaction.