Table 3.

Secondary outcomes at the end of synbiotic and placebo intervention

VariableAll Completers (n=31)Antibiotic-Free Completers (n=21)
SynbioticsPlaceboP ValueaSynbioticsPlaceboP Valuea
Kidney related
 EPI GFR, ml/min per 1.73 m224±824±80.6723±723±70.46
 Serum creatinine, μmol/L231±75233±740.94236±72241±740.59
 Kidney injury molecule-1 (n=27), ng/ml1.1 (0.4–2.7)1.1 (0.4–2.1)0.121.0 (0.3–1.7)1.1 (0.3–1.7)0.54
 Proteinuria (n=28), mg/24 h369 (162–1550)323 (169–1150)0.20803 (175–1550)466 (224–1250)0.13
 Albuminuria (n=30), mg/24 h112 (16–758)111 (12–594)0.03b393 (47–970)240 (102–715)0.19
Inflammatory
 IL-1β, pg/ml0.8±0.70.8±0.60.980.8±0.60.8±0.70.36
 IL-6, pg/ml2.2±0.92.0±0.80.402.0±0.82.0±0.90.86
 IL-10, pg/ml3.6±2.03.6±2.10.843.4±1.73.7±2.10.32
 TNF-α, pg/ml2.2±0.82.0±0.70.092.1±0.72.1±0.70.58
Oxidative stress
 F2-isoprostanes, pg/ml141±76167±1120.16127±63139±970.68
 Glutathione peroxidase, U/L157±6155±70.19157±7155±70.37
Exploratory
 Endotoxins, EU/ml0.29±0.130.27±0.130.160.29±0.130.27±0.120.18
Patient reported health (n=27)
 Physical composite score35±1137±100.2334±1037±100.48
 Mental composite score51±1052±90.7550±1052±90.67
Gastrointestinal Symptom Score (n=30)
 Mean score1.6±0.71.5±0.80.721.7±0.71.5±0.80.49
 Score >3, n (%)
  Reflux0 (0)1 (3)>0.99b0 (0)1 (5)>0.99b
  Abdominal pain0 (0)0 (0)>0.99b0 (0)0 (0)>0.99b
  Indigestion4 (13)2 (7)0.69b4 (19)1 (5)0.38b
  Constipation2 (7)5 (17)0.25b1 (5)3 (14)0.50b
  Diarrhea3 (10)1 (3)0.50b3 (14)1 (5)0.50b
Dietary intake
 Energy
  Diet history, MJ7.6±2.57.4±2.50.197.9±2.77.7±2.70.08
  Body weight, kg80±1880±180.4780±2180±210.43
 Protein
  Diet history, g79±2480±240.7580±2682±270.46
  Estimated from 24-h urinary urea nitrogen, g67±2070±190.3868±2372±200.24
 Fiberd, g23±923±90.3824±924±100.15
  • Data presented as means±SDs or medians (interquartile ranges). Score >3 indicates moderate discomfort. EPI, epidemiology collaboration; MJ, megajoules.

  • a Derived from regression modeling with normally distributed data and Wilcoxon Mann–Whitney with non-normal data, with both methods accounting for period effect.

  • b Treatment effect of 38 mg/24 h.

  • c Exact McNemar significance probability.

  • d From diet only and not including synbiotic supplement.