Abstract
BackgroundLactose 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.ObjectiveThe 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.MethodsThe 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.ResultsLongitudinal 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.ConclusionsThe 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.
Highlights
Lactose maldigestion is a common condition affecting up to 75 % of the world's population [1]
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
When the amount of ingested lactose exceeds the hydrolytic capacity of lactase in the intestine, undigested lactose is transported to the large intestine where it is fermented by the bacterial microflora, producing organic acids, carbon dioxide, and hydrogen
Summary
Lactose maldigestion is a common condition affecting up to 75 % of the world's population [1]. When the amount of ingested lactose exceeds the hydrolytic capacity of lactase in the intestine, undigested lactose is transported to the large intestine where it is fermented by the bacterial microflora, producing organic acids, carbon dioxide, and hydrogen. These byproducts, along with the large amount of water osmotically drawn into the intestine, lead to the commonly known symptoms of abdominal pain, bloating, cramps, and flatulence [4, 5]. Preclinical studies have found that Lactobacillus acidophilus supplementation may assist in breaking down lactose; no human clinical trials exist evaluating its efficacy in alleviating symptoms related to lactose intolerance
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