Clinical study
Phage 3Determination of Phage/Probiotic Synergistic Effects on Gastrointestinal Health
| Status | Completed |
|---|---|
| Type | Adjacent product trial |
| Countries | United States |
| Conditions studied | Gastrointestinal Dysfunction |
| Study years | 2021–2024 |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
Inclusion Criteria: * Equal numbers of healthy male and female volunteers between 18-75 years old with BMI scores of 18.5 to 34.9. Exclusion Criteria: * Individuals less than 18years of age or greater than 75years of age. * If an individual's BMI is outside of 18.5-34.9. * History of taking antibiotics and/or probiotics/prebiotics supplementation within 2months of starting antibiotics. * If individual is on any medications and dietary supplements that would influence the endpoints of the study, such as statins, metformin, NSAIDs and MAO inhibitors. * If individuals with diagnosis with cancer, liver or kidney disease, gastrointestinal diseases and metabolic disorders. * Pregnant and breastfeeding women. * Additionally inclusion and exclusion in the study will be determined case by case based on self reported alcohol and supplement use. * If individual is unable to adhere to study protocol such as consuming capsules for a total 45days, providing stool or blood samples and attending scheduled clinic visits.
Study description
The goal of this double blinded clinical trial is to determine whether consumption of the PreforPro product, when co-consumed with Bacillus subtilis DE111 probiotic, synergistically improves bowel regularity, perceived physical symptoms of gastrointestinal distress and other aspects of gastrointestinal health over probiotic use alone. Therefore, the primary goal of this study is to see if PreforPro consumption concurrent with B. subtilis DE111 usage improves probiotic activity. The secondary goal of this study is to assess non-gastrointestinal physiologic parameters to determine whether consumption of PreforPro combined with the probiotic offers any additional health benefits (ie. reduced inflammation, improved gut microbiota profiles) beyond those of consuming a probiotic alone. Participants will be asked to track daily bowel movements for 7 days prior to beginning capsule consumption and record their diet for a total 3 of days (two weekdays and one weekend day). They will then be asked to consume the provided capsules daily for a period of 45 days. Researchers will compare three parallel arms; (1) PreforPro+B. subtilis DE111 probiotic, (2) B. subtilis DE111 alone, or (3) a maltodextrin placebo to establish their impact on gastrointestinal symptoms and other indicators of health.
Study registrations
| ClinicalTrials.gov | NCT05750433 |
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Recorded study locations (1)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University
Fort Collins, Colorado, United States
Recorded site status: Not separately listed. Study location source ↗
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct05750433 |
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