The study is a randomized, double-blind, crossover, placebo-controlled clinical intervention trial to test the effects of a commercial Bacillus (Shouchella) clausii probiotic compared to a placebo on gastrointestinal symptoms.
Prospective participants are pre-qualified by email screening and attended an in-person study visit at Colorado State University's Food and Nutrition Clinical Research Laboratory (FNCRL) in the Department of Food Science and Human Nutrition. During the initial visit, participants signed the Consent Form after the nature of the procedure had been fully explained to them. Their eligibility is confirmed by taking anthropometric measurements of height (cm) and weight (kg) to calculate BMI and by completing a written medical health questionnaire to determine medical history and current medication use. Eligible participants are then assigned sequentially to a study code (MS01, MS02, etc.), and codes were pre-assigned to intervention sequences using a random number generator in Microsoft Excel. For the initial clinic visit (and subsequent visits), participants are fasted for at least 8 hours and asked to abstain from alcohol use for at least 12 hours prior to clinic visits. They were also instructed to refrain from taking any non-prescription medications for 24 hours or dietary supplements for 12 hours before their visits. At the initial visit, a venous blood sample was collected, and participants filled out several assessment forms/questionnaires: GI Health Appraisal Questionnaire, GI Symptom Rating Scale (GSRS), GI Quality of Life Questionnaire (IBS-QOL Questionnaire) 7-day Physical Activity Recall, Positive and Negative Affect Schedule, and Perceived Stress Scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
55
Gram-positive, spore-forming microorganism
Inert filler material delivered in a capsule identical to the probiotic intervention
Food and Nutrition Clinical Research Laboratory
Fort Collins, Colorado, United States
Adverse Event Rate
For each arm adverse event forms were tracked and the total rate of adverse events was calculated
Time frame: 12 weeks
Gastrointestinal symptom rating score
Gastrointestinal symptoms were assessed using the gastrointestinal symptom rating score, at the beginning and end of each intervention period. The GSRS is a 15-item scale where each item can be scored 1-7 according to symptom severity. A minimum score is 15 and the maximum score is 110. The higher score indicates more severe symptoms.
Time frame: 12 weeks
Gut microbiota composition
The gut microbiota composition was assessed by 16s rRNA at the beginning and end of each intervention period.
Time frame: 12 weeks
Systemic Inflammation
PBMCs were collected at the beginning and end of each intervention period and then cultured and stimulated with bacterial LPS. Collected supernatants were assessed using a multiplex ELISA for T-cell activity.
Time frame: 12 weeks
Regularity of Bowel Movements
A Bristol stool scale was used to record daily bowel movements throughout the study to determine changes in bowel movement regularity.
Time frame: 13 weeks
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