Background
Methods
Participants and study design
Scoring method | ||
---|---|---|
Target | 1 | 0 |
Straining# | Baseline: Straining more than 25% of defecations. Post-WMT: Frequency of straining unchanged or increased compared to baseline | (i) No straining (ii) Straining less than 25% of defecations. |
Hard stools# | Baseline: Lumpy or hard stools more than 25% of defecations. Post-WMT: Frequency of hard stools unchanged or increased compared to baseline | (i) No hard stools (ii) Lumpy or hard stools less than 25% of defecations. |
Incomplete evacuation# | Baseline: Sensation of incomplete evacuation more than 25% of defecations. Post-WMT: Frequency of incomplete evacuation unchanged or increased compared to baseline | (i) No straining (ii) Sensation of incomplete evacuation less than 25% of defecations. |
Anorectal obstruction# | Baseline: Sensation of anorectal obstruction/blockage more than 25% of defecations. Post-WMT: Frequency of anorectal obstruction unchanged or increased compared to baseline | (i) No anorectal obstruction (ii) Sensation of anorectal obstruction/blockage less than 25% of defecations. |
Decreased stool frequency* | Baseline: fewer than three spontaneous complete bowel movements per week. Post-WMT: Frequency of SCBMs/week unchanged or decreased compared to baseline | Three or more spontaneous complete bowel movements per week. |
Donor screening and WMT procedures
Follow-up of patients after the first WMT procedure and evaluation of adverse events
Assessment of efficacy and safety
Identification of the potential factors influencing the efficacy of WMT in treating FC
Statistical analysis
Results
Patients’ characteristics
Baseline characteristics | Improvement of therapeutic targets and overall response& | ||||||||
---|---|---|---|---|---|---|---|---|---|
Straining (26 vs. 34) | Hard stools (28 vs. 29) | Incomplete evacuation (6 vs. 8) | Anorectal obstruction (5 vs. 4) | Decreased stool frequency (26 vs. 20) | Overall response (31 vs. 32) | ||||
Sex | |||||||||
Male (n = 29) | 46.0% | 61.5% vs. 52.9% | 53.6% vs. 55.2% | 66.7% vs. 50.0% | 80.0% vs. 75.0% | 53.8% vs. 40.0% | 61.3% vs. 46.9% | ||
Female (n = 44) | 54.0% | 38.5% vs. 47.1% | 46.4% vs. 44.8% | 33.3% vs. 50.0% | 20.0% vs. 25.0% | 46.2% vs. 60.0% | 38.7% vs. 53.1% | ||
Age, year | 60.8 ± 15.0 | 61.7 ± 12.1 vs. 59.5 ± 17.2 | 62.3 ± 11.7 vs. 58.9 ± 17.6 | 58.0 ± 15.9 vs. 67.5 ± 15.8 | 62.2 ± 7.7 vs. 71.5 ± 3.3 | 62.2 ± 12.2 vs. 59.0 ± 18.0 | 62.7 ± 12.5 vs. 60.0 ± 17.1 | ||
Duration of disease, year | 6 (2–12) | 6.5 (2.0–20.0) vs. 6.5 (2.75–10.5) | 7 (3-17.5) vs.6 (1–11) | 2 (0.5–10) vs.7.5 (1.75–17.5) | 3 (1.5–25) vs.6 (1.25–13.75) | 8.5 (3-22.5) vs.6 (1–10) | 7 (3–20) vs.6 (1–10) | ||
Number of SCBMs/week | 2 (1–3) | 5.0 (3.75–6.25) vs.2.5 (2.0–3.0)* | 4 (3–6) vs.2 (2–3)* | 6 (2.75-7) vs.3.5 (2.25–6.75) | 5 (3-6.5) vs.4.5 (2.25–6.75) | 3 (3–6) vs.2 (2–2)* | 5 (3–6) vs.2 (2–3)* | ||
BSFS score | 2 (1–2) | 3.0 (3.0–4.0) vs.2.0 (2.0–3.0)* | 3 (3-3.75) vs.2 (2–2)* | 3 (3-4.25) vs.2 (2-3.75) | 4 (2.5–4.5) vs.2.5 (1.25–3.75) | 3 (2.75-4) vs.2 (2–2)* | 3 (3–4) vs.2 (2–2)* | ||
Wexner constipation score | 9 (8–11) | 5 (3-7.25) vs.9 (8–10)* | 6 (4–7) vs.10 (8-10.5)* | 4 (2.75-6) vs.9 (7.25-10)* | 7 (1.5-8) vs.8 (3.25–9.75) | 7 (4.75-9) vs.9.5 (8–10)* | 6 (4–8) vs.9 (8–10)* | ||
WMT delivery routes | |||||||||
Mid-gut (n = 25) Lower-gut (n = 38) | 39.7% 60.3% | 34.6% vs. 41.2% 65.4% vs. 58.8% | 32.1% vs. 48.3% 67.9% vs. 51.7% | 50.0% vs.12.5% 50.0% vs.87.5% | 40.0% vs. 25.0% 60.0% vs.75.0% | 34.6% vs. 40.0% 65.4% vs.60.0% | 32.3% vs. 46.9% 67.7% vs.53.1% | ||
History of laxative use | 76.2% | 61.5% vs. 85.3%* | 71.4% vs.82.8% | 66.7% vs. 87.5% | 80.0% vs. 50.0% | 76.9% vs. 80.0% | 67.7% vs. 84.4% |
Baseline characteristics | Improvement of therapeutic targets and overall response& | ||||||||
---|---|---|---|---|---|---|---|---|---|
Straining (27 vs. 33) | Hard stools (26 vs. 31) | Incomplete evacuation (6 vs. 8) | Anorectal obstruction (5 vs. 4) | Decreased stool frequency (28 vs. 18) | Overall response (32 vs. 31) | ||||
Sex | |||||||||
Male (n = 29) | 46.0% | 55.6% vs. 57.6% | 53.8% vs. 54.8% | 66.7% vs. 50.0% | 80.0% vs. 75.0% | 50.0% vs. 44.4% | 56.3% vs. 51.6% | ||
Female (n = 44) | 54.0% | 44.4% vs. 42.4% | 46.2% vs. 45.2% | 33.3% vs. 50.0% | 20.0% vs. 25.0% | 50.0% vs. 55.6% | 43.8% vs. 48.4% | ||
Age, year | 60.8 ± 15.0 | 61.3 ± 12.0 vs. 59.7 ± 17.4 | 61.5 ± 11.7 vs. 59.8 ± 17.4 | 58.0 ± 15.9 vs. 67.5 ± 15.8 | 62.2 ± 7.7 vs. 71.5 ± 3.3 | 61.7 ± 12.2vs. 59.5 ± 18.7 | 60.3 ± 12.1 vs. 61.1 ± 17.6 | ||
Duration of disease, year | 6 (2–12) | 7 (2–15) vs. 6 (2.5–13.5) | 10 (3–20) vs. 5 (1–10) | 2 (0.5–10) vs. 7.5 (1.75–17.5) | 3 (1.5–25) vs.6 (1.25–13.75) | 7 (3-18.75) vs.6 (1–10) | 7 (3-13.75) vs.6 (1–12) | ||
Number of SCBMs/week | 2 (1–3) | 5 (4–6) vs.3 (2–3)* | 5 (3.75-6) vs.2 (2–3)* | 5.5 (4–7) vs.3.5 (2.25–6.75) | 4 (3–6) vs.4.5 (2.25–6.75) | 4 (3-5.75) vs.2 (1–2)* | 5 (3.25-6) vs.2 (2–3)* | ||
BSFS score | 2 (1–2) | 4 (3–4) vs.2 (2–3)* | 3 (3–4) vs.2 (2–2)* | 3.5 (3-4.25) vs.2 (2-3.75)** | 3 (2.5–4.5) vs.2.5 (1.25–3.75) | 3 (3–4) vs.2 (1.75-2)* | 3.5 (3–4) vs.2 (2–2)* | ||
Wexner constipation score | 9 (8–11) | 6 (4–7) vs.10 (8–11)* | 6 (4–7) vs.10 (8–11)* | 5.5 (3–8) vs.9 (6.5–10)** | 7 (3.5–12.5) vs.7.5 (3.25–9.5) | 6 (5.25–9.5) vs.10 (8-10.25)* | 6 (4–7) vs.10 (8–11)* | ||
Course of WMT | 1 (1–3) | 2 (1–3) vs.1 (1–2)* | 2 (1–3) vs.1 (1–2)* | 3 (1–3) vs.1 (1–2) | 1 (1–3) vs.1 (1-1.75) | 2 (1–3) vs.1 (1–1)* | 2 (1–3) vs.1 (1–1)* | ||
1 (n = 37)# | 58.7% | 40.7% vs. 72.7% | 46.2% vs. 74.2% | 33.3% vs. 62.5% | 60.0% vs. 75.0% | 32.1% vs. 94.4% | 37.5% vs. 80.6% | ||
2 (n = 10) | 15.9% | 22.2% vs. 9.1%** | 19.2% vs. 12.9% | 0.0% vs. 25.0% | 0.0% vs. 25.0% | 21.4% vs. 5.6%* | 25.0% vs. 6.5%* | ||
3 (n = 16) | 25.4% | 37.0% vs. 18.2%* | 34.6% vs. 12.9%* | 66.75 vs. 12.5% | 40.0% vs. 0.0% | 46.4% vs. 0.0% | 37.5% vs. 12.9%* | ||
Course of WMT ≥ 2 (n = 26) | 41.3% | 59.3% vs. 27.3%* | 53.8% vs. 25.8%* | 66.7% vs. 37.5% | 40.0% vs. 25.0% | 67.9% vs. 5.6%* | 62.5% vs. 19.4%* | ||
History of laxative use | 76.2% | 63.0% vs. 84.8%** | 73.1% vs. 80.6% | 66.7% vs. 87.5% | 80.0% vs. 50.0% | 75.0% vs. 83.3% | 68.8% vs. 83.9% |
Baseline characteristics | Improvement of therapeutic targets and overall response& | ||||||
---|---|---|---|---|---|---|---|
Straining (21 vs. 39) | Hard stools (22 vs. 35) | Incomplete evacuation (5 vs. 9) | Anorectal obstruction (4 vs. 5) | Decreased stool frequency (23 vs. 23) | Overall response (27 vs. 36) | ||
Sex | |||||||
Male (n = 29) | 46.0% | 57.1% vs. 56.4% | 50.0% vs. 57.1% | 60.0% vs. 55.6% | 75.0% vs. 80.0% | 52.2% vs. 43.5% | 55.6% vs. 52.8% |
Female (n = 44) | 54.0% | 42.9% vs. 43.6% | 50.0% vs. 42.9% | 40.0%vs. 44.4% | 25.0% vs. 20.0% | 47..8% vs. 56.5% | 44.4% vs. 47.2% |
Age, year | 60.8 ± 15.0 | 62.0 ± 10.7 vs. 60.0 ± 17.1 | 61.0 ± 11.6 vs. 60.3 ± 17.0 | 62.8 ± 12.0 vs. 63.8 ± 6.2 | 59.3 ± 4.6 vs. 72.0 ± 3.1 | 60.7 ± 11.0 vs.61.0 ± 18.3 | 61.4 ± 10.9 vs. 60.4 ± 17.5 |
Duration of disease, year | 6 (2–12) | 10 (4-12.5) vs. 6 (1–15) | 10 (4.5–20) vs. 5 (1–10) | 3 (0.5–10) vs. 5 (1–15) | 11.5 (2.25–27.5) vs. 2 (1-12.5) | 10 (5–20) vs. 5 (1–10)** | 10 (3–15) vs. 5 (1-11.5) |
Number of SCBMs/week | 2 (1–3) | 5 (4–6) vs. 2 (2–3)* | 5 (3-5.25) vs. 2 (2–3)* | 5 (3-6.5) vs. 4 (2–7) | 4.5 (2.5–6.5) vs.3 (2-6.5) | 4 (3–5) vs. 2 (2–2)* | 5 (3–6) vs. 2 (2–3)* |
BSFS score | 2 (1–2) | 3 (3–4) vs. 2 (2–3)* | 3 (3–4) vs. 2 (2–2)* | 3 (2.5-4) vs. 2 (1.5–4.5) | 3.5 (2.25–4.75) vs. 2 (1.5–3.5) | 3 (3–4) vs. 2 (2–2)* | 3 (3–4) vs. 2 (2–2)* |
Wexner constipation score | 9 (8–11) | 6 (3–7) vs. 9 (8–10)* | 6 (3-7.25) vs. 9 (8–10)* | 6 (3-9.5) vs. 9 (6–10) | 9 (2.5-11.75) vs. 8 (4.5–9.5) | 7 (5–9) vs. 9 (8–10)* | 6 (3–8) vs. 9 (8–10)* |
Course of WMT | 1 (1–3) | 2 (1-2.5) vs. 1 (1–3) | 1.5 (1–3) vs. 1 (1–2) | 3 (1-3.5) vs. 1 (1-2.5) | 1 (1-2.5) vs. 1 (1-2.5) | 2 (1–3) vs. 1 (1–2)* | 2 (1–3) vs. 1 (1–2)* |
1 (n = 37)# | 58.7% | 47.6% vs. 64.1% | 50.0% vs. 68.6% | 40.0% vs. 55.6% | 75.0% vs. 60.0% | 39.1% vs. 73.9% | 40.7% vs. 72.2% |
2 (n = 10) | 15.9% | 28.6% vs. 7.7%* | 22.7% vs. 11.4% | 0.0% vs. 22.2% | 0.0% vs. 20.0% | 17.4% vs. 13.0% | 25.9% vs. 8.3%* |
3 (n = 9) | 14.3% | 4.8% vs. 20.5% | 9.1% vs. 14.3% | 40.0% vs. 11.1% | 25.0% vs. 20.0% | 26.1% vs. 13.0% | 14.8% vs. 13.9% |
4 (n = 7) | 11.1% | 19.0% vs. 7.7% | 18.2% vs. 5.7% | 20.0% vs. 11.1% | 0.0% vs. 0.0% | 17.4% vs. 0.0% | 18.5% vs. 5.6%** |
Course of WMT ≥2 (n = 26) | 41.3% | 52.4% vs. 35.9% | 50.0% vs. 31.4% | 60.0% vs. 44.4% | 25.0% vs. 40.0% | 60.9% vs. 26.1%* | 59.3% vs. 27.8%* |
History of laxative use | 76.2% | 57.1% vs. 84.6%* | 72.7% vs. 80.0% | 60.0% vs. 88.9% | 75.0% vs. 60.0% | 78.3% vs. 78.3% | 70.4% vs. 80.6% |
Primary efficacy outcomes of WMT for individual therapeutic targets of FC
Secondary efficacy and safety outcomes of WMT for FC
Adverse event* | On days of infusion | During follow-up |
---|---|---|
Fever | 0 (0.0) | 0 (0.0) |
Diarrhea | 8 (7.0) | 1 (0.9) |
Abdominal pain | 4 (3.6) | 1 (0.9) |
Nausea | 1 (0.9) | 0 (0.0) |
Increased bloating | 4 (3.6) | 2 (1.8) |
Vomiting | 1 (0.9) | 0 (0.0) |
Overall | 18 | 4 |
Factors influencing the efficacy of WMT treatment
Variable | At week 8 | At week 24 | ||
---|---|---|---|---|
Odds ratio (95% CI) | P-value | Odds ratio (95% CI) | P-value | |
Primary outcomes | ||||
Straining improvement rate | 4.458 (1.412–14.075) | 0.011 | 2.177 (0.693–6.836) | 0.183 |
Hard stools improvement rate | 3.354 (1.101–10.222) | 0.033 | 2.182 (0.727–6.548) | 0.164 |
Decreased stool frequency improvement rate Overall response | 35.889 (4.109-313.423) 6.944 (2.215–21.776) | 0.001 0.001 | 4.897 (1.322–18.139) 3.782 (1.312–10.903) | 0.017 0.014 |
Secondary outcomes | ||||
Clinical remission rate | 4.571 (1.222–17.097) | 0.024 | 2.109 (0.558–7.975) | 0.272 |
Clinical improvement rate | 10.214 (1.398–74.623) | 0.022 | 5.668 (1.436–22.363) | 0.013 |