Pakdaman Michael N, Udani Jay K, Molina Jhanna Pamela, Shahani Michael
Pakdaman Consulting, 22287 Mulholland Hwy #269, Calabasas, CA, 91302, USA.
Northridge Hospital Integrative Medicine Program, 18300 Roscoe Blvd, Northridge, CA, 91328, USA.
Nutr J. 2016 May 20;15(1):56. doi: 10.1186/s12937-016-0172-y.
Lactose intolerance is a form of lactose maldigestion where individuals experience symptoms such as diarrhea, abdominal cramping, flatulence, vomiting and bowel sounds following lactose consumption. Lactobacillus acidophilus is a species of bacteria known for its sugar fermenting properties. Preclinical studies have found that Lactobacillus acidophilus supplementation may assist in breaking down lactose; however, no human clinical trials exist evaluating its efficacy in alleviating symptoms related to lactose intolerance.
The aim of this randomized, double-blind, placebo-controlled, crossover study was to evaluate the effect of a proprietary strain of Lactobacillus acidophilus on relieving discomfort related to lactose intolerance.
The study enrolled healthy volunteers between 18 and 75 years of age who complained of lactose intolerance. Screening visits included a lactose challenge visit to confirm eligibility based on a score of 10 or higher on subjective assessment of the following symptoms after lactose challenge: diarrhea, abdominal cramping, vomiting, audible bowel sounds, flatulence, and overall symptoms. Qualified subjects participated in a 2-arm crossover design, with each arm consisting of 4 weeks of intervention of either active or placebo product, with a 2-week washout period during crossover. The study product consisted of the DDS-1 strain of Lactobacillus acidophilus (Nebraska Cultures, Walnut Creek, California). The placebo was formulated from maltodextrin. Study participants were instructed to take the product once daily for 4 weeks. Data collected included subjective symptom scores related to lactose intolerance.
Longitudinal comparison between the DDS-1 group and placebo group demonstrated statistically significant reductions in abdominal symptom scores during the 6-h Lactose Challenge at week 4 for diarrhea (p = 0.033), abdominal cramping (p = 0.012), vomiting (p = 0.0002), and overall symptom score (p = 0.037). No adverse events were reported.
The present study has found that this unique DDS-1 strain of Lactobacillus acidophilus, manufactured by Nebraska Cultures, is safe to consume and improves abdominal symptom scores compared to placebo with respect to diarrhea, cramping, and vomiting during an acute lactose challenge.
乳糖不耐受是乳糖消化不良的一种形式，个体在摄入乳糖后会出现腹泻、腹部绞痛、肠胃胀气、呕吐和肠鸣音等症状。嗜酸乳杆菌是一种以其糖发酵特性而闻名的细菌。临床前研究发现，补充嗜酸乳杆菌可能有助于分解乳糖；然而，尚无人体临床试验评估其缓解乳糖不耐受相关症状的疗效。
这项随机、双盲、安慰剂对照、交叉研究的目的是评估一种专利嗜酸乳杆菌菌株缓解乳糖不耐受相关不适的效果。
该研究招募了18至75岁主诉乳糖不耐受的健康志愿者。筛查访视包括一次乳糖激发试验访视，根据乳糖激发试验后以下症状主观评估得分为10分或更高来确认 eligibility：腹泻、腹部绞痛、呕吐、可闻及的肠鸣音、肠胃胀气和总体症状。符合条件的受试者参与双臂交叉设计，每臂包括4周的活性或安慰剂产品干预，交叉期间有2周的洗脱期。研究产品由嗜酸乳杆菌DDS-1菌株（内布拉斯加培养物公司，加利福尼亚州核桃溪市）组成。安慰剂由麦芽糊精配制而成。研究参与者被指示每天服用该产品一次，持续4周。收集的数据包括与乳糖不耐受相关的主观症状评分。
DDS-1组和安慰剂组之间的纵向比较表明，在第4周的6小时乳糖激发试验期间，腹泻（p = 0.033）、腹部绞痛（p = 0.012）、呕吐（p = 0.0002）和总体症状评分（p = 0.037）的腹部症状评分在统计学上有显著降低。未报告不良事件。
本研究发现，内布拉斯加培养物公司生产的这种独特的嗜酸乳杆菌DDS-1菌株食用安全，与安慰剂相比，在急性乳糖激发试验期间，在腹泻、绞痛和呕吐方面可改善腹部症状评分。
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