Gastrointestinal Health
Conditions
Keywords
Gastrointestinal health, Intestinal inflammation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBacillus (Shouchella) clausii CSI08
Gram-positive, spore-forming microorganism
OTHERPlacebo
Inert filler material delivered in a capsule identical to the probiotic intervention
Sponsors
Colorado State University
ADM Deerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Capsules for the intervention and placebo were produced and coded by ADM Deerland and they held the blinding codes until after the primary outcomes were analyzed.
Intervention model description
The trial will be a double-blinded, randomized, placebo-controlled crossover intervention study taking place at Colorado State University.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-75 * BMI 18-34.9 * self report as healthy * consistent Mild to Moderate gastrointestinal distress (determined by a functional GI screen)
Exclusion criteria
* \<18 or \>75 * BMI \<18 or \>34.9 * antibiotics within two months * probiotic/prebiotic supplements within two weeks prior to the screening process * pregnant or breastfeeding * taking medications that influence study endpoints of the study (i.e., statins, metformin, nonsteroidal anti-inflammatory drugs, and monoamine oxidase inhibitors) * a current diagnosis of cancer, liver or kidney disease, metabolic disorders, and GI diseases (Celiac disease, inflammatory bowel disease, and peptic ulcer disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Rate | 12 weeks | For each arm adverse event forms were tracked and the total rate of adverse events was calculated |
| Gastrointestinal symptom rating score | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition | 12 weeks | The gut microbiota composition was assessed by 16s rRNA at the beginning and end of each intervention period. |
| Systemic Inflammation | 12 weeks | 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. |
| Regularity of Bowel Movements | 13 weeks | A Bristol stool scale was used to record daily bowel movements throughout the study to determine changes in bowel movement regularity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTiffany L Weir, PhD
CSU
STUDY_DIRECTORAllegra L Vazquez, MS
CSU
Outcome results
None listed