Details

Autor(en) / Beteiligte

• Freedman, Stephen B
• Horne, Rachael
• Johnson-Henry, Kathene
• Xie, Jianling
• Williamson-Urquhart, Sarah
• Chui, Linda
• Pang, Xiao-Li
• Lee, Bonita
• Schuh, Suzanne
• Finkelstein, Yaron
• Gouin, Serge
• Farion, Ken J
• Poonai, Naveen
• Hurley, Katrina
• Schnadower, David
• Sherman, Philip M

Titel

Probiotic stool secretory immunoglobulin A modulation in children with gastroenteritis: a randomized clinical trial

Ist Teil von

• The American journal of clinical nutrition, 2021-04, Vol.113 (4), p.905-914

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2021

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• We previously conducted the Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment (PROGUT) study, which identified no improvements in children with acute gastroenteritis (AGE) administered a probiotic. However, the aforementioned study did not evaluate immunomodulatory benefits. The object of this study was to determine if stool secretory immunoglobulin A (sIgA) concentrations in children with AGE increase more among participants administered a Lactobacillus rhamnosus/helveticus probiotic compared with those administered placebo. This a priori planned multicenter, randomized, double-blinded, placebo-controlled ancillary study enrolled children presenting for emergency care who received a 5-d probiotic or placebo course. Participants submitted stool specimens on days 0, 5, and 28. The primary endpoint was the change in stool sIgA concentrations on day 5 compared with baseline. A total of 133 (n = 66 probiotic, 67 placebo) of 886 PROGUT participants (15.0%) provided all 3 specimens. Median stool sIgA concentrations did not differ between the probiotic and placebo groups at any of the study time points: day 0 median (IQR): 1999 (768, 4071) compared with 2198 (702, 5278) (P = 0.27, Cohen’s d = 0.17); day 5: 2505 (1111, 5310) compared with 3207 (982, 7080) (P = 0.19, Cohen’s d = 0.16); and day 28: 1377 (697, 2248) compared with 1779 (660, 3977) (P = 0.27, Cohen’s d = 0.19), respectively. When comparing measured sIgA concentrations between days 0 and 5, we found no treatment allocation effects [β: −0.24 (−0.65, 0.18); P = 0.26] or interaction between treatment and specimen collection day [β: −0.003 (−0.09, 0.09); P = 0.95]. Although stool sIgA decreased between day 5 and day 28 within both groups (P < 0.001), there were no differences between the probiotic and placebo groups in the median changes in sIgA concentrations when comparing day 0 to day 5 median (IQR) [500 (−1135, 2362) compared with 362 (−1122, 4256); P = 0.77, Cohen’s d = 0.075] and day 5 to day 28 [−1035 (−3130, 499) compared with −1260 (−4437, 843); P = 0.70, Cohen’s d = 0.067], respectively. We found no effect of an L. rhamnosus/helveticus probiotic, relative to placebo, on stool IgA concentrations. This trial was registered at clinicaltrials.gov as NCT01853124.