补充剂在感染中的作用：一项安慰剂对照、单盲研究。
The effect of supplementation in infection: a placebo-controlled, single-blind study.
作者信息
Buckley Martin, Lacey Sean, Doolan Andrea, Goodbody Emily, Seamans Kelly
机构信息
1Mercy University Hospital, Grenville Place, Centre, Cork, T12 WE28 Ireland.
2Cork Institute of Technology, Rossa Avenue, Bishopstown, Cork, T12 P928 Ireland.
出版信息
BMC Nutr. 2018 Dec 7;4:48. doi: 10.1186/s40795-018-0257-4. eCollection 2018.
BACKGROUND
is the major cause of chronic gastritis, and considered as a risk factor for peptic ulcer and gastric cancer. The standard antibiotic therapy fails in about 25-30% of cases, particularly because of the increasing occurrence of resistance to antibiotics. The aim of the current study was to investigate whether the strain DSM17648 which has been previously shown to reduce load additionally improves gastrointestinal symptoms in positive subjects when used in a 28 days supplementation.
METHODS
In a single-blinded, placebo controlled study 24 -positive adults (13 females, 11 males; median age: 43.5) with mild dyspepsia (mean GSRS score: 11.82) received placebo for 28 days followed by Pylopass™ containing the DSM 17648 (2 × 10 cells per day) for the following 28 days. After 28 days of Pylopass supplementation the change in load was measured by C urea breath test (C-UBT) and the change in symptoms were determined by the Gastrointestinal Symptom Rating Scale (GSRS). In addition, blood assessments were conducted to measure the physiological changes relevant in terms of safety.
RESULTS
After a 28-day supplementation phase with Pylopass there was a trend for reduction of load in 62.5% of the subjects and for the overall GSRS scores in 66.7% of subjects. The overall GSRS scores from baseline to day 56 following all 24 subjects undergoing the placebo phase followed by the Pylopass™ phase was significantly decreased ( = 0.005). The mean 13C-UBT δ value decreased by 22.5% during the Pylopass™ supplementation phase (- 3.14), while the mean 13C-UBT δ increased by 37.3% (+ 3.79) in the placebo phase. No side effects were reported in either study phase.
CONCLUSION
The results demonstrated that DSM17648 has the potential to suppress infection, and may lead to an improvement of -associated gastro intestinal symptoms. Further studies with adequate power should be performed.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT02051348 (January 30, 2014).
背景
幽门螺杆菌是慢性胃炎的主要病因，被认为是消化性溃疡和胃癌的危险因素。标准抗生素疗法在约25%-30%的病例中失败，尤其是因为对抗生素耐药性的发生率不断增加。本研究的目的是调查先前已证明可降低幽门螺杆菌负荷的DSM17648菌株在进行28天补充剂使用时，是否能额外改善幽门螺杆菌阳性受试者的胃肠道症状。
方法
在一项单盲、安慰剂对照研究中，24名幽门螺杆菌阳性的成年人（13名女性，11名男性；中位年龄：43.5岁），有轻度消化不良（平均GSRS评分：11.82），先接受28天的安慰剂，随后在接下来的28天接受含有DSM 17648（每天2×10⁹个细胞）的Pylopass™。在补充Pylopass 28天后，通过¹³C尿素呼气试验（¹³C-UBT）测量幽门螺杆菌负荷的变化，并通过胃肠道症状评定量表（GSRS）确定症状的变化。此外，进行血液评估以测量与安全性相关的生理变化。
结果
在使用Pylopass进行28天补充期后，62.5%的受试者有幽门螺杆菌负荷降低的趋势，66.7%的受试者有总体GSRS评分降低的趋势。在所有24名受试者经历安慰剂期后接着是Pylopass™期，从基线到第56天的总体GSRS评分显著降低（P = 0.005）。在Pylopass™补充期，平均¹³C-UBT δ值下降了22.5%（-3.14），而在安慰剂期平均¹³C-UBT δ值增加了37.3%（+3.79）。在两个研究阶段均未报告副作用。
结论
结果表明DSM17648有抑制幽门螺杆菌感染的潜力，并可能导致与幽门螺杆菌相关的胃肠道症状得到改善。应进行有足够效力的进一步研究。
试验注册
Clinicaltrials.gov：NCT02051348（2014年1月30日）
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