Establishing Effects of Bacillus Clausii Probiotic Consumption on Gastrointestinal Health and Inflammation (MUNISPORE)

Colorado State University (CSU)

Status

Completed

Conditions

Gastrointestinal Health

Treatments

Dietary Supplement: Bacillus (Shouchella) clausii CSI08

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07618026

4176

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)