- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07618026
Establishing Effects of Bacillus Clausii Probiotic Consumption on Gastrointestinal Health and Inflammation (MUNISPORE)
26 maj 2026 uppdaterad av: Colorado State University
MUNISPORE: Establishing Effects of Bacillus Clausii Probiotic Consumption on Gastrointestinal Health and Inflammation
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
55
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Colorado
-
Fort Collins, Colorado, Förenta staterna, 80523
- Food and Nutrition Clinical Research Laboratory
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Bacillus (Shouchella) clausii
1x10^9 CFU of Bacillus clausii CSI08 provided in a 300 mg capsule with a rice maltodextrin and coconut triglycerides mixture as the filler.
|
Gram-positive, spore-forming microorganism
Andra namn:
|
|
Placebo-jämförare: Placebo
The placebo was a 300mg capsule containing a rice maltodextrin and coconut triglycerides mixture.
|
Inert filler material delivered in a capsule identical to the probiotic intervention
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse Event Rate
Tidsram: 12 weeks
|
For each arm adverse event forms were tracked and the total rate of adverse events was calculated
|
12 weeks
|
|
Gastrointestinal symptom rating score
Tidsram: 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.
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gut microbiota composition
Tidsram: 12 weeks
|
The gut microbiota composition was assessed by 16s rRNA at the beginning and end of each intervention period.
|
12 weeks
|
|
Systemic Inflammation
Tidsram: 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.
|
12 weeks
|
|
Regularity of Bowel Movements
Tidsram: 13 weeks
|
A Bristol stool scale was used to record daily bowel movements throughout the study to determine changes in bowel movement regularity.
|
13 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood Lipids
Tidsram: 12 weeks
|
Blood lipids were assessed using collected whole blood samples at the beginning and end of each intervention period using a Piccolo Xpress Blood Lipid Panel.
|
12 weeks
|
|
Liver Toxicity
Tidsram: 12 weeks
|
A comprehensive metabolic panel will be performed on whole blood collected at the beginning and end of each intervention period using a Piccolo Xpress Comprehensive Metabolic Panel.
This includes multiple markers, that when considered together, can provide an indication of liver toxicity.
Specifically, out-of-range values for alanine amino transferase (ALT), asparagine amino transferase (AST), alkaline phosphatase (AST), bilirubin, albumin, and total protein can collectively be interpreted to look for indication of hepatocellular or cholestatic injury.
|
12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Tiffany L Weir, PhD, CSU
- Studierektor: Allegra L Vazquez, MS, CSU
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 mars 2024
Primärt slutförande (Faktisk)
31 mars 2025
Avslutad studie (Faktisk)
31 mars 2025
Studieregistreringsdatum
Först inskickad
16 februari 2026
Först inskickad som uppfyllde QC-kriterierna
26 maj 2026
Första postat (Faktisk)
1 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 4176
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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