Table 2 Primary and Secondary outcomes

From: Gut microbiota modulation via repeated donor fecal transplantation improves motor and gastrointestinal symptoms in drug-naïve Parkinson’s disease: a randomized phase 2 trial

Outcome

aFMT

dFMT

Adjusted mean difference (95% CI)

p value

Primary outcome: change from baseline to 35w in UPDRS III, mean (SD)

 Difference

0.1 (1.1)

−3.8 (1.2)

−3.9 (−5.8, −2.0)

0.0001

Secondary outcome measures

 Change in UPDRS I, mean (SD)

 Between baseline and 11w

0.1 (0.1)

−0.2 (0.1)

−0.3 (−0.6, 0.1)

0.1166

 Between baseline and 23w

0.1 (0.1)

−0.1 (0.1)

−0.1 (−0.3, 0.1)

0.4899

 Between baseline and 35w

0.2 (0.1)

0.0 (0.1)

−0.2 (−0.5, 0.2)

0.2971

Change in UPDRS II, mean (SD)

 Between baseline and 11w

−0.1 (0.2)

−0.5 (0.2)

−0.5 (−0.9, −0.1)

0.0255

 Between baseline and 23w

0.1 (0.2)

−0.4 (0.2)

−0.5 (−0.9, −0.1)

0.0184

 Between baseline and 35w

0.0 (0.2)

−0.3 (0.2)

−0.3 (−0.7, 0.1)

0.1062

Change in UPDRS III, mean (SD)

 Between baseline and 11w

−1.6 (1.4)

−7.3 (1.4)

−5.7 (−7.5, −3.8)

< 0.0001

 Between baseline and 23w

−0.6 (1.1)

−5.2 (1.2)

−4.6 (−6.5, −2.6)

< 0.0001

Change in CSS, mean (SD)

 Between baseline and 11w

−3.8 (0.7)

−6.3 (0.7)

−2.5 (−3.7, −1.3)

0.0001

 Between baseline and 23w

−2.1 (0.8)

−6.5 (0.7)

−4.3 (−5.5, −3.1)

< 0.0001

 Between baseline and 35w

−0.7 (0.8)

−6.5 (0.7)

−5.8 (−7.0, −4.6)

< 0.0001

Change in GSRS, mean (SD)

 Between baseline and 11w

−2.3 (0.5)

−3.5 (0.5)

−1.1 (−1.9, −0.4)

0.0041

 Between baseline and 23w

−2.2 (0.5)

−3.1 (0.5)

−0.9 (−1.6, −0.1)

0.0292

 Between baseline and 35w

−1.3 (0.5)

−2.7 (0.5)

−1.4 (−2.2, −0.6)

0.0004

Change in GSRS-LDT, mean (SD)

 Between baseline and 11w

−1.5 (0.3)

−2.8 (0.3)

−1.5 (−2.0, −0.9)

< 0.0001

 Between baseline and 23w

−1.6 (0.3)

−2.5 (0.3)

−1.1 (−1.6, −0.5)

0.0001

 Between baseline and 35w

−1.5 (0.3)

−2.7 (0.3)

−1.3 (−1.9, −0.8)

< 0.0001

Change in PAC-QoL, mean (SD)

 Between baseline and 11w

−0.2 (0.1)

−0.4 (0.1)

−0.3 (−0.5, −0.2)

< 0.0001

 Between baseline and 23w

−0.1 (0.1)

−0.3 (0.1)

−0.3 (−0.5, −0.2)

< 0.0001

 Between baseline and 35w

−0.1 (0.1)

−0.3 (0.1)

−0.3 (−0.5, −0.2)

< 0.0001

Change in PDQ-39, mean (SD)

 Between baseline and 11w

−1.2 (1.7)

−5.5 (2.0)

−4.3 (−6.7, −2.0)

0.0043

 Between baseline and 23w

0.1 (1.6)

−5.0 (1.9)

−5.1 (−7.4, −2.8)

0.0014

 Between baseline and 35w

1.5 (1.5)

−4.2 (1.8)

−5.7 (−8.0, −3.4)

0.0006

Change in SCOPA-AUT, mean (SD)

 Between baseline and 11w

−2.3 (0.5)

−4.8 (0.5)

−2.5 (−3.7, −1.3)

0.0001

 Between baseline and 23w

−2.4 (0.5)

−3.0 (0.5)

−0.5 (−1.7, 0.7)

0.3946

 Between baseline and 35w

0.8 (0.5)

−0.1 (0.5)

−1.0 (−2.2, 0.2)

0.1133

Change in MMSE, mean (SD)

 Between baseline and 11w

0.2 (0.1)

0.1 (0.1)

−0.1 (−0.3, 0.1)

0.1979

 Between baseline and 23w

0.1 (0.1)

0.0 (0.1)

−0.0 (−0.2, 0.2)

0.6755

 Between baseline and 35w

0.2 (0.1)

0.1 (0.1)

−0.1 (−0.3, 0.1)

0.3706

Change in MoCA, mean (SD)

 Between baseline and 11w

−0.0 (0.2)

0.3 (0.2)

0.3 (−0.1, 0.6)

0.1079

 Between baseline and 23w

0.2 (0.1)

0.1 (0.1)

−0.0 (−0.3, 0.2)

0.8349

 Between baseline and 35w

0.0 (0.1)

0.1 (0.1)

0.1 (−0.2, 0.4)

0.6861

Dopamine levels, mean (SD), ng/mL

 11w

253.38 (273.46)

286.72 (241.79)

33.33 (−97.27, 163.90)

0.6065

 35w

115.30 (97.85)

390.76 (361.33)

275.5 (144.90, 406.00)

0.0002

DOPAC levels, mean (SD), ng/mL

 11w

469.44 (460.86)

593.13 (287.07)

123.70 (−100.40, 347.80)

0.2683

 35w

339.62 (274.66)

576.24 (284.60)

236.6 (77.54, 395.7)

0.0049

Dopamine/DOPAC ratio, mean (SD)

 11w

2.41 (1.26)

0.64 (0.62)

−0.75 (−1.45, −0.06)

0.0334

 35w

0.62 (0.57)

1.19 (0.92)

0.34 (−0.11, 0.79)

0.1371

Histological score, mean (SD)

 11w

3.95 (1.33)

3.24 (0.94)

−0.68 (−1.40, 0.05)

0.0666

 35w

4.29 (0.98)

2.94 (0.80)

−1.34 (−2.07, −0.62)

0.0005

% integrated optical density of pα-syn, mean (SD)

 11w

13.65 (4.41)

13.05 (3.86)

−0.59 (−3.85, 2.66)

0.7032

 35w

14.71 (4.83)

11.10 (3.30)

−3.60 (−6.81, −0.39)

0.0301

Mean integrated density of E-ca in the colon, mean (SD)

 11w

31.81 (5.55)

39.53 (6.45)

7.72 (4.17, 11.27)

0.0003

 35w

27.98 (3.42)

49.66 (6.98)

21.68 (17.47, 25.90)

< 0.0001

  1. The primary and secondary outcomes between treatment groups were assessed on an intention-to-treat basis via 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
  2. BMI body mass index (calculated as weight in kilograms divided by height in meters squared), SD standard deviation, H&Y Hoehn & Yahr, UPDRS Unified Parkinson’s Disease Rating Scale, PDQ-39 39-item Parkinson’s Disease Questionnaire, CSS Constipation Scoring System, GSRS Gastrointestinal Symptom Rating Scale, PAC-QoL Patient Assessment of Constipation-Quality of Life, SCOPA-AUT Scales for Outcomes in Parkinson’s Disease-Autonomic, MMSE Mini-Mental State Examination, MoCA Montreal Cognitive Assessment, GSRS-LDT GSRS lower digestive tract subscale, dFMT donor fecal microbiota transplantation, aFMT autologous fecal microbiota transplantation, w week, E-ca E-cadherin
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