IBS Research and Probiotics
How Atlantia’s Solution Helped Atlantia’s world-class team of doctors, scientist, nutritionists, and research nurses worked closely with the Sponsors’ researchers to design and deliver the study objectives. Atlantia’s expert team in stress and anxiety was a perfect fit for the sponsors research needs. was recommended by our expert team. Each participant served as his/her own control and both interventions (the investigational product and Placebo) were evaluated for the same individual. This allowed the same precision as a parallel group trial with only half the sample size. A crossover study design About the Study The underlying factors contributing to IBS are heterogeneous and not completely understood but it is considered that altered gut mucosal immune activation cognitive function, psychological stress, brain-gut interaction and changes in the gut microbiota are significant contributors to the condition.
DESIGN
ETHICS
RECRUITMENT
CONDUCT
ANALYSIS
REPORTING
Atlantia first performed a pilot study to estimate the carryover effect and determine the washout period required for the randomized, double-blind, placebo-controlled crossover study and provide preliminary data on the subject characteristics and variation in the parameters measured. In both the pilot and crossover study, we measured stress and mood using validated questionnaires aand other biological biomarkers. Bowel symptoms were measured using self-reported measures of abdominal pain, passage of gas, stool form and consistency as well as straining and bowel movement urgency on a daily basis using an eDiary system. Other measures will include weekly global assessment of IBS symptoms and abdominal pain/discomfort.
atlantiaclinicaltrials.com
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