‘Sixth largest clinical trial’ supports probiotics for digestive health
The study, which is said to be the sixth largest probiotic-digestive health clinical trial, used either Lactobacillus acidophilus DDS-1 or Bifidobacterium animalis subsp. lactis UABla-12 for six weeks. Over 300 people participated in the study.
Data published in Nutrients indicated that both probiotic strains led to significant improvements in the IBS Symptom Severity Scale, compared to placebo, and this included symptoms like abdominal pain and bloating, bowel habits, and quality of life.
“Both probiotic strains helped improve total symptomology as per the validated questionnaire, with changes that could be classified as clinically significant,” wrote Christopher Martoni and Gregory Leyer from UAS Labs (USA) and Shalini Srivastava from Vedic Lifesciences (India).
DDS-1 science
Commenting on the study, Dr Leyer stated: “While the research supporting our DDS-1 strain of L. acidophilus is copious, this clinical trial provided the opportunity to continue growing its portfolio. We have promised our partners that our foundation is built on science, and this study upholds our commitment”.
“Adding B. lactis as a separate arm allowed us to evaluate two different probiotic genera for optimal performance. We are beyond thrilled with the impact both have shown on digestive health,” he added.
Study details
The randomized, double-blind, placebo-controlled, multi-center study included 330 adults at 12 sites throughout India. All the participants had IBS according to Rome IV criteria. Volunteers were randomly assigned to one of three groups: placebo, Lactobacillus acidophilus DDS-1 (10 billion CFU/day), or Bifidobacterium animalis subsp. lactis UABla-12 (10 billion CFU/day) for six weeks.
Results showed that Abdominal Pain Severity - Numeric Rating Scale (APS-NRS), which was the primary outcome, significantly improved in both probiotic groups, compared to placebo.
The scientists also reported significant amelioration in IBS Symptom Severity Scale (IBS-SSS) scores for bot probiotics, compared to placebo.
In addition, participants in both probiotic groups experienced a “significant normalization in stool consistency”, compared to placebo.
“FDA guidance defines a responder as a decrease in weekly average abdominal pain of at least 30% compared to baseline,” wrote Martoni, Srivastava, and Leyer. “Clinically significant responders in the current study, considering the entire ITT population including dropouts, were 52.3% and 28.2% in the L. acidophilus DDS-1 and B. lactis UABla-12 groups respectively, both of which were significantly higher than placebo (15.6%).
“It is of interest that both probiotic strains, most notably L. acidophilus DDS-1, showed a significant group response as well an individual response to intervention.
“The high responder rates observed herein may also be applicable more generally. Episodes of abdominal pain occur in healthy people as well as individuals with IBS with the difference being the frequency and severity of symptoms. Therefore, according to the European Food Safety Authority, IBS patients are generally an appropriate study group to substantiate claims related to gastrointestinal discomfort in the general population.”
Source: Nutrients
12(2), 363; doi: 10.3390/nu12020363
“Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial”
Authors: C.J. Martoni et al.
