Characteristic and demographic data for all SSc patients from the ReSScue FMT pilot trial, receiving FMT or placebo, and from unselected SSc control patients
| . | ReSScue patients (n = 9) . | FMT intervention (n = 5) . | Placebo intervention (n = 4) . | SSc control patients (n = 17) . |
|---|---|---|---|---|
| Age at sampling, mean years (s.d.) | 62 (5.7) | 58 (5.6) | 66 (1.5) | 52 (4.8) |
| Female, n (%) | 9 (100) | 5 (100) | 4 (100) | 17 (100) |
| Disease duration, mean years (s.d.) | 12.0 (10.6) | 7.4 (6.7) | 17.8 (12.6) | 5.3 (4.2) |
| lcSSc, n (%) | 9 (100) | 5 (100) | 4 (100) | 10 (59) |
| ACA, n (%) | 8 (89) | 5 (100) | 3 (75) | 8 (47) |
| Anti-Scl-70 antibody, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (15) |
| GIT involvement | ||||
| Oesophagal involvement, n (%) | 9 (100) | 5 (100) | 4 (100) | 13 (76) |
| Dysphagia, n (%) | 8 (89) | 4 (80) | 4 (100) | 8 (47) |
| Reflux disease, n (%) | 4 (44) | 3 (60) | 1 (25) | 11 (73) |
| GAVE, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (12) |
| Diarrhoea, n (%) | 5 (56) | 3 (60) | 2 (50) | 5 (29) |
| Distension/Bloating, n (%) | 7 (78) | 5 (100) | 2 (50) | 10 (59) |
| Obstipation, n (%) | 7 (78) | 4 (80) | 3 (75) | 5 (29) |
| Soilage/Incontinence, n (%) | 1 (11) | 0 (0) | 1 (25) | 4 (24) |
| UCLA-GIT Score | 0.7 (0.5) | 0.7 (0.4) | 0.8 (0.6) | 0.7 (0.8) |
| Lung involvement | ||||
| ILD, n (%) | 2 (22) | 2 (40) | 0 (0) | 6 (35) |
| FVC, mean (s.d.), predicted | 86.8 (28.2) | 78.2 (34.8) | 97 (10.4) | 97.6 (27) |
| FEV1, mean (s.d.) | 83.9 (14.3) | 86.6 (13.5) | 80.5 (14.5) | 81.7 (18.5) |
| DLCO, mean (s.d.) | 74.4 (13.4) | 76.4 (12) | 72 (18) | 63.9 (22.1) |
| PAH, n (%) | 0 (0) | 0 (0) | 0 (0) | 3 (18) |
| Cutaneus manifestation | ||||
| Digital ulcers, n (%) | 0 (0) | 0 (0) | 0 (0) | 8 (47) |
| Calcinosis, n (%) | 3 (33) | 2 (40) | 1 (25) | 7 (41) |
| Telangiectasia, n (%) | 6 (67) | 3 (60) | 3 (75) | 13 (76) |
| mRSS, mean (s.d.) | 4.9 (4.8) | 4.3 (3.8) | 5.5 (5.6) | 7 (5.5) |
| Renal involvement | ||||
| Scleroderma Renal Crisis, n (%) | 0 (0) | 0 (0) | 0 (0) | 1 (6) |
| Medication | ||||
| Proton Pump Inhibitor, n (%) | 7 (77) | 3 (60) | 4 (100) | 2 (12) |
| MMF, n (%) | 1 (11) | 1 (20) | 0 (0) | 3 (17) |
| MTX, n (%) | 1 (11) | 0 (0) | 1 (25) | 2 (12) |
| CSs, n (%) | 2 (22) | 1 (20) | 1 (25) | 4 (24) |
| Rituximab, n (%) | 1 (11) | 0 (0) | 1 (25) | 1 (6) |
| . | ReSScue patients (n = 9) . | FMT intervention (n = 5) . | Placebo intervention (n = 4) . | SSc control patients (n = 17) . |
|---|---|---|---|---|
| Age at sampling, mean years (s.d.) | 62 (5.7) | 58 (5.6) | 66 (1.5) | 52 (4.8) |
| Female, n (%) | 9 (100) | 5 (100) | 4 (100) | 17 (100) |
| Disease duration, mean years (s.d.) | 12.0 (10.6) | 7.4 (6.7) | 17.8 (12.6) | 5.3 (4.2) |
| lcSSc, n (%) | 9 (100) | 5 (100) | 4 (100) | 10 (59) |
| ACA, n (%) | 8 (89) | 5 (100) | 3 (75) | 8 (47) |
| Anti-Scl-70 antibody, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (15) |
| GIT involvement | ||||
| Oesophagal involvement, n (%) | 9 (100) | 5 (100) | 4 (100) | 13 (76) |
| Dysphagia, n (%) | 8 (89) | 4 (80) | 4 (100) | 8 (47) |
| Reflux disease, n (%) | 4 (44) | 3 (60) | 1 (25) | 11 (73) |
| GAVE, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (12) |
| Diarrhoea, n (%) | 5 (56) | 3 (60) | 2 (50) | 5 (29) |
| Distension/Bloating, n (%) | 7 (78) | 5 (100) | 2 (50) | 10 (59) |
| Obstipation, n (%) | 7 (78) | 4 (80) | 3 (75) | 5 (29) |
| Soilage/Incontinence, n (%) | 1 (11) | 0 (0) | 1 (25) | 4 (24) |
| UCLA-GIT Score | 0.7 (0.5) | 0.7 (0.4) | 0.8 (0.6) | 0.7 (0.8) |
| Lung involvement | ||||
| ILD, n (%) | 2 (22) | 2 (40) | 0 (0) | 6 (35) |
| FVC, mean (s.d.), predicted | 86.8 (28.2) | 78.2 (34.8) | 97 (10.4) | 97.6 (27) |
| FEV1, mean (s.d.) | 83.9 (14.3) | 86.6 (13.5) | 80.5 (14.5) | 81.7 (18.5) |
| DLCO, mean (s.d.) | 74.4 (13.4) | 76.4 (12) | 72 (18) | 63.9 (22.1) |
| PAH, n (%) | 0 (0) | 0 (0) | 0 (0) | 3 (18) |
| Cutaneus manifestation | ||||
| Digital ulcers, n (%) | 0 (0) | 0 (0) | 0 (0) | 8 (47) |
| Calcinosis, n (%) | 3 (33) | 2 (40) | 1 (25) | 7 (41) |
| Telangiectasia, n (%) | 6 (67) | 3 (60) | 3 (75) | 13 (76) |
| mRSS, mean (s.d.) | 4.9 (4.8) | 4.3 (3.8) | 5.5 (5.6) | 7 (5.5) |
| Renal involvement | ||||
| Scleroderma Renal Crisis, n (%) | 0 (0) | 0 (0) | 0 (0) | 1 (6) |
| Medication | ||||
| Proton Pump Inhibitor, n (%) | 7 (77) | 3 (60) | 4 (100) | 2 (12) |
| MMF, n (%) | 1 (11) | 1 (20) | 0 (0) | 3 (17) |
| MTX, n (%) | 1 (11) | 0 (0) | 1 (25) | 2 (12) |
| CSs, n (%) | 2 (22) | 1 (20) | 1 (25) | 4 (24) |
| Rituximab, n (%) | 1 (11) | 0 (0) | 1 (25) | 1 (6) |
mRSS: modified Rodnan Skin Score; GIT: gastrointestinal tract; GERD: gastroesophageal reflux disease; GAVE: gastric antral vascular ectasia; UCLA-GIT score: University of California Los Angeles Gastrointestinal score; ILD: interstitial lung disease; FMT: faecal microbiota transplantation; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; DLCO: diffuse capacity of the lung carbon monoxide; PAH: pulmonary arterial hypertension.
Characteristic and demographic data for all SSc patients from the ReSScue FMT pilot trial, receiving FMT or placebo, and from unselected SSc control patients
| . | ReSScue patients (n = 9) . | FMT intervention (n = 5) . | Placebo intervention (n = 4) . | SSc control patients (n = 17) . |
|---|---|---|---|---|
| Age at sampling, mean years (s.d.) | 62 (5.7) | 58 (5.6) | 66 (1.5) | 52 (4.8) |
| Female, n (%) | 9 (100) | 5 (100) | 4 (100) | 17 (100) |
| Disease duration, mean years (s.d.) | 12.0 (10.6) | 7.4 (6.7) | 17.8 (12.6) | 5.3 (4.2) |
| lcSSc, n (%) | 9 (100) | 5 (100) | 4 (100) | 10 (59) |
| ACA, n (%) | 8 (89) | 5 (100) | 3 (75) | 8 (47) |
| Anti-Scl-70 antibody, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (15) |
| GIT involvement | ||||
| Oesophagal involvement, n (%) | 9 (100) | 5 (100) | 4 (100) | 13 (76) |
| Dysphagia, n (%) | 8 (89) | 4 (80) | 4 (100) | 8 (47) |
| Reflux disease, n (%) | 4 (44) | 3 (60) | 1 (25) | 11 (73) |
| GAVE, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (12) |
| Diarrhoea, n (%) | 5 (56) | 3 (60) | 2 (50) | 5 (29) |
| Distension/Bloating, n (%) | 7 (78) | 5 (100) | 2 (50) | 10 (59) |
| Obstipation, n (%) | 7 (78) | 4 (80) | 3 (75) | 5 (29) |
| Soilage/Incontinence, n (%) | 1 (11) | 0 (0) | 1 (25) | 4 (24) |
| UCLA-GIT Score | 0.7 (0.5) | 0.7 (0.4) | 0.8 (0.6) | 0.7 (0.8) |
| Lung involvement | ||||
| ILD, n (%) | 2 (22) | 2 (40) | 0 (0) | 6 (35) |
| FVC, mean (s.d.), predicted | 86.8 (28.2) | 78.2 (34.8) | 97 (10.4) | 97.6 (27) |
| FEV1, mean (s.d.) | 83.9 (14.3) | 86.6 (13.5) | 80.5 (14.5) | 81.7 (18.5) |
| DLCO, mean (s.d.) | 74.4 (13.4) | 76.4 (12) | 72 (18) | 63.9 (22.1) |
| PAH, n (%) | 0 (0) | 0 (0) | 0 (0) | 3 (18) |
| Cutaneus manifestation | ||||
| Digital ulcers, n (%) | 0 (0) | 0 (0) | 0 (0) | 8 (47) |
| Calcinosis, n (%) | 3 (33) | 2 (40) | 1 (25) | 7 (41) |
| Telangiectasia, n (%) | 6 (67) | 3 (60) | 3 (75) | 13 (76) |
| mRSS, mean (s.d.) | 4.9 (4.8) | 4.3 (3.8) | 5.5 (5.6) | 7 (5.5) |
| Renal involvement | ||||
| Scleroderma Renal Crisis, n (%) | 0 (0) | 0 (0) | 0 (0) | 1 (6) |
| Medication | ||||
| Proton Pump Inhibitor, n (%) | 7 (77) | 3 (60) | 4 (100) | 2 (12) |
| MMF, n (%) | 1 (11) | 1 (20) | 0 (0) | 3 (17) |
| MTX, n (%) | 1 (11) | 0 (0) | 1 (25) | 2 (12) |
| CSs, n (%) | 2 (22) | 1 (20) | 1 (25) | 4 (24) |
| Rituximab, n (%) | 1 (11) | 0 (0) | 1 (25) | 1 (6) |
| . | ReSScue patients (n = 9) . | FMT intervention (n = 5) . | Placebo intervention (n = 4) . | SSc control patients (n = 17) . |
|---|---|---|---|---|
| Age at sampling, mean years (s.d.) | 62 (5.7) | 58 (5.6) | 66 (1.5) | 52 (4.8) |
| Female, n (%) | 9 (100) | 5 (100) | 4 (100) | 17 (100) |
| Disease duration, mean years (s.d.) | 12.0 (10.6) | 7.4 (6.7) | 17.8 (12.6) | 5.3 (4.2) |
| lcSSc, n (%) | 9 (100) | 5 (100) | 4 (100) | 10 (59) |
| ACA, n (%) | 8 (89) | 5 (100) | 3 (75) | 8 (47) |
| Anti-Scl-70 antibody, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (15) |
| GIT involvement | ||||
| Oesophagal involvement, n (%) | 9 (100) | 5 (100) | 4 (100) | 13 (76) |
| Dysphagia, n (%) | 8 (89) | 4 (80) | 4 (100) | 8 (47) |
| Reflux disease, n (%) | 4 (44) | 3 (60) | 1 (25) | 11 (73) |
| GAVE, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (12) |
| Diarrhoea, n (%) | 5 (56) | 3 (60) | 2 (50) | 5 (29) |
| Distension/Bloating, n (%) | 7 (78) | 5 (100) | 2 (50) | 10 (59) |
| Obstipation, n (%) | 7 (78) | 4 (80) | 3 (75) | 5 (29) |
| Soilage/Incontinence, n (%) | 1 (11) | 0 (0) | 1 (25) | 4 (24) |
| UCLA-GIT Score | 0.7 (0.5) | 0.7 (0.4) | 0.8 (0.6) | 0.7 (0.8) |
| Lung involvement | ||||
| ILD, n (%) | 2 (22) | 2 (40) | 0 (0) | 6 (35) |
| FVC, mean (s.d.), predicted | 86.8 (28.2) | 78.2 (34.8) | 97 (10.4) | 97.6 (27) |
| FEV1, mean (s.d.) | 83.9 (14.3) | 86.6 (13.5) | 80.5 (14.5) | 81.7 (18.5) |
| DLCO, mean (s.d.) | 74.4 (13.4) | 76.4 (12) | 72 (18) | 63.9 (22.1) |
| PAH, n (%) | 0 (0) | 0 (0) | 0 (0) | 3 (18) |
| Cutaneus manifestation | ||||
| Digital ulcers, n (%) | 0 (0) | 0 (0) | 0 (0) | 8 (47) |
| Calcinosis, n (%) | 3 (33) | 2 (40) | 1 (25) | 7 (41) |
| Telangiectasia, n (%) | 6 (67) | 3 (60) | 3 (75) | 13 (76) |
| mRSS, mean (s.d.) | 4.9 (4.8) | 4.3 (3.8) | 5.5 (5.6) | 7 (5.5) |
| Renal involvement | ||||
| Scleroderma Renal Crisis, n (%) | 0 (0) | 0 (0) | 0 (0) | 1 (6) |
| Medication | ||||
| Proton Pump Inhibitor, n (%) | 7 (77) | 3 (60) | 4 (100) | 2 (12) |
| MMF, n (%) | 1 (11) | 1 (20) | 0 (0) | 3 (17) |
| MTX, n (%) | 1 (11) | 0 (0) | 1 (25) | 2 (12) |
| CSs, n (%) | 2 (22) | 1 (20) | 1 (25) | 4 (24) |
| Rituximab, n (%) | 1 (11) | 0 (0) | 1 (25) | 1 (6) |
mRSS: modified Rodnan Skin Score; GIT: gastrointestinal tract; GERD: gastroesophageal reflux disease; GAVE: gastric antral vascular ectasia; UCLA-GIT score: University of California Los Angeles Gastrointestinal score; ILD: interstitial lung disease; FMT: faecal microbiota transplantation; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; DLCO: diffuse capacity of the lung carbon monoxide; PAH: pulmonary arterial hypertension.
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