Gastrointestinal DysfunctionNCT05750433
Phage 3Determination of Phage/Probiotic Synergistic Effects on Gastrointestinal Health
A study testing PreforPro+B. subtilis DE111 probiotics and B. subtilis DE111 in people with Gastrointestinal Dysfunction, run by Colorado State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- PreforPro+B. subtilis DE111 probiotics and B. subtilis DE111
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Equal numbers of healthy male and female volunteers between 18-75 years old with BMI scores of 18.5 to 34.9.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University
Fort Collins, Colorado, 80526
About this study
Official title: PHAGE 3: Determination of Phage and Probiotic Synergistic Effects on Gastrointestinal Health
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.
Read the detailed description
This is a continuation of previous intervention studies exploring the impacts of a bacteriophage formulation, PreforPro, on gastrointestinal health. The purpose of this study is to determine if the PreforPro product acts synergistically with a spore-based probiotic to influence bowel habits, perceptions of gastrointestinal symptoms, microbiota composition and inflammatory and immune parameters. The proposed study will also explore a longer intervention duration than the previous studies. A secondary outcome will include measuring plasma lipids, as the proposed probiotics (B. subtilis DE111) was shown to improve total and LDL cholesterol levels in our previous study. Bacteriophages may directly influence the microbiota and intestinal environment by selectively infecting host species- in this case E. coli. Additionally, they may have indirect effects as infection of target species can open up ecological niches and/or result in assimilation of released nutrients by other commensal organisms. These phages are generally regarded as safe for human consumption and specifically infecting several strains of E. coli, including enterohemorrhagic strains and Shiga-toxin producing strains. The removal of these E. coli alters the gut environment to allow growth of more favorable bacteria. We have previously shown that PreforPro is both safe and tolerable in a human population and does not broadly disrupt the gut microbiota as would be seen with antibiotic treatment. It did not improve the survival of Bifidobacterium lactis probiotic, but did appear to amplify some of its impacts on perceived functional gastrointestinal health.
A phone screening will be conducted of all interested individuals to evaluate their eligibility. Those meeting the initial eligibility criteria will be scheduled for a clinic visit to obtain informed consent and to confirm eligibility. Consent will be obtained at the Colorado State University Food and Nutrition Clinical Research Lab (FNCRL) by a screening questionnaire and interview/assessment by the clinical coordinator. After securing consent, eligibility will be confirmed by taking anthropometric measures and participants falling within the BMI range will randomly be assigned to 1 of 3 treatment groups: (1) PreforPro+B. subtilis DE111 probiotic, (2) B. subtilis DE111 alone, or (3) maltodextrin placebo.
Visit 1 (baseline): Eligible individuals will be asked to visit the clinic at visit 1 (baseline) to provide consent and confirm eligibility, undergo sample collections (blood and stool) and analysis procedures (weight/height, hip:waist ratio, gastrointestinal symptoms/ quality of life questionnaires) and receive their stool collection container, a stool log and 3-day diet log. Participants will be schedule for their drop off visit, in which they will return to the clinic 7 days after their first visit (Visit 2, Day 0) to return their stool sample, stool log and 3-day diet record. In return, they will be provided with another stool collection kit, their treatment capsules, another stool log and 3-day diet log. At the end of the 45-day treatment period (Visit 3-Final), final blood and stool samples will be collected as well as additional analyses (such as GI questionnaires, stool logs and 3-day diet record). This means that participants will undergo screening (by phone) and make a total of three (3) visits to the clinic during the study (baseline, Day 0, Final). All blood samples will be collected at Colorado State University by trained personnel. Fecal sample collection will be performed by the study participant with collection materials provided by Colorado State University.
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- PreforPro+B. subtilis DE111 probiotics, Placebo, B. subtilis DE111
- Keywords
- PreforPro, Probiotics, Bacillus subtilis, Prebiotics, Gut health, Gut microbiota, Synergistic effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreforPro+B. subtilis DE111 probioticsDietary supplement
PreforPro is bacteriophage-based product which was used in combination with Bacillus subtilis probiotics.
PlaceboDietary supplement
Maltodextrin is rice based powder which was used as placebo.
B. subtilis DE111Dietary supplement
Bacillus subtilis probiotics.
| Study group | Role | What they receive |
|---|---|---|
| PreforPro+B. subtilis DE111 probiotics | Experimental | PreforPro is a prebiotic which is a bacteriophage-based product. This prebiotic was used in combination with Bacillus subtilis probiotics. Receives: Dietary Supplement: PreforPro+B. subtilis DE111 probiotics |
| Placebo(maltodextrin) | Placebo comparator | Maltodextrin was used as a placebo. Receives: Dietary Supplement: Placebo |
| B. subtilis DE111 alone | Active comparator | Bacillus subtilis probiotics was used in this arm alone to compare with the experimental arm. Receives: Dietary Supplement: B. subtilis DE111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Health Questionnaire
Self-assessment of functional measures of gastrointestinal health, including colon and small intestinal pain, gastric function, and gastrointestinal inflammation.
Measured: Evaluated at Baseline and Final (52 days apart) with questions designed to capture function from the prior 4 weeks.
Bowel Movement Diary
Daily recording of the number and type (based on Bristol Stool chart) of bowel movements.
Measured: 52 days
Quality of Life Assessment
Questionnaire that evaluates the impact of gastrointestinal health on daily activities as well as social and psychological impacts.
Measured: Evaluated at Baseline and Final (52 days apart)
Secondary outcomes (7)
Gut microbiota changes (beta-diversity)
16s amplicon sequencing of stool samples will be conducted and analyzed for beta-diversity (differences between samples) using principle coordinate analysis of Bray Curtis distances.
Measured: 2 samples per person, collected ~7 weeks apart
Gut microbiota changes (alpha diversity)
16s amplicon sequencing of stool samples will be conducted and analyzed for alpha diversity differences by applying actual and boot-strapped species number estimates, and Shannon and Simpson diversity indices.
Measured: 2 samples per person, collected ~7 weeks apart
Intestinal inflammation
Intestinal inflammation will be assessed by levels of fecal calprotectin measured by ELISA
Measured: 2 samples per person, collected ~7 weeks apart
Intestinal inflammation
Intestinal inflammation will be assessed by levels of secretory immunoglobin A measured by ELISA
Measured: 2 samples per person, collected ~7 weeks apart
Systemic inflammation
Human T-cell associated markers of inflammation in the blood will be measured using a multi-plex Luminex panel for 13 analytes.
Measured: 2 blood samples per person, collected ~7 weeks apart
Systemic inflammation
Cultured PBMCs will be stimulated with bacterial LPS and the supernatants will be analyzed for TNF-alpha, Il-6, 1l-10 and IFN-gamma using ELISA.
Measured: 2 blood samples per person, collected ~7 weeks apart
Lipid panels
The Piccolo Xpress lipid panel will be used with a 200ul blood sample to measure total cholesterol and other blood lipid parameters.
Measured: 2 blood samples per person, collected ~7 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Oct 2021
- Primary completion23 Dec 2022
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Archer Daniels Midland Company
- Responsible party
- Principal investigator, Tiffany Weir, Colorado State University
- Investigators
- Tiffany L Weir, MSc,PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750433
- Sponsor's protocol ID
- 1676
- Status last verified
- Jun 2024
- First submitted
- 20 Feb 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freedman KE, Hill JL, Wei Y, Vazquez AR, Grubb DS, Trotter RE, Wrigley SD, Johnson SA, Foster MT, Weir TL. Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis DE111. Int J Mol Sci. 2021 Feb 28;22(5):2453. doi: 10.3390/ijms22052453.
PubMed 33671071Grubb DS, Wrigley SD, Freedman KE, Wei Y, Vazquez AR, Trotter RE, Wallace TC, Johnson SA, Weir TL. PHAGE-2 Study: Supplemental Bacteriophages Extend Bifidobacterium animalis subsp. lactis BL04 Benefits on Gut Health and Microbiota in Healthy Adults. Nutrients. 2020 Aug 17;12(8):2474. doi: 10.3390/nu12082474.
PubMed 32824480Trotter RE, Vazquez AR, Grubb DS, Freedman KE, Grabos LE, Jones S, Gentile CL, Melby CL, Johnson SA, Weir TL. Bacillus subtilis DE111 intake may improve blood lipids and endothelial function in healthy adults. Benef Microbes. 2020 Nov 15;11(7):621-630. doi: 10.3920/BM2020.0039. Epub 2020 Nov 9.
PubMed 33161737Gindin M, Febvre HP, Rao S, Wallace TC, Weir TL. Bacteriophage for Gastrointestinal Health (PHAGE) Study: Evaluating the Safety and Tolerability of Supplemental Bacteriophage Consumption. J Am Coll Nutr. 2019 Jan;38(1):68-75. doi: 10.1080/07315724.2018.1483783. Epub 2018 Aug 29.
PubMed 30157383Febvre HP, Rao S, Gindin M, Goodwin NDM, Finer E, Vivanco JS, Lu S, Manter DK, Wallace TC, Weir TL. PHAGE Study: Effects of Supplemental Bacteriophage Intake on Inflammation and Gut Microbiota in Healthy Adults. Nutrients. 2019 Mar 20;11(3):666. doi: 10.3390/nu11030666.
PubMed 30897686
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHAGE 3: Determination of Phage and Probiotic Synergistic Effects on Gastrointestinal Health
- ClinicalTrials.gov ID
- NCT05750433
- Acronym / sponsor ID
- 1676
- Conditions
- Gastrointestinal Dysfunction
- Keywords
- PreforPro, Probiotics, Bacillus subtilis, Prebiotics, Gut health, Gut microbiota, Synergistic effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Archer Daniels Midland Company
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a continuation of previous intervention studies exploring the impacts of a bacteriophage formulation, PreforPro, on gastrointestinal health. The purpose of this study is to determine if the PreforPro product acts synergistically with a spore-based probiotic to influence bowel habits, perceptions of gastrointestinal symptoms, microbiota composition and inflammatory and immune parameters. The proposed study will also explore a longer intervention duration than the previous studies. A secondary outcome will include measuring plasma lipids, as the proposed probiotics (B. subtilis DE111) was shown to improve total and LDL cholesterol levels in our previous study. Bacteriophages may directly influence the microbiota and intestinal environment by selectively infecting host species- in this case E. coli. Additionally, they may have indirect effects as infection of target species can open up ecological niches and/or result in assimilation of released nutrients by other commensal organisms. These phages are generally regarded as safe for human consumption and specifically infecting several strains of E. coli, including enterohemorrhagic strains and Shiga-toxin producing strains. The removal of these E. coli alters the gut environment to allow growth of more favorable bacteria. We have previously shown that PreforPro is both safe and tolerable in a human population and does not broadly disrupt the gut microbiota as would be seen with antibiotic treatment. It did not improve the survival of Bifidobacterium lactis probiotic, but did appear to amplify some of its impacts on perceived functional gastrointestinal health.
A phone screening will be conducted of all interested individuals to evaluate their eligibility. Those meeting the initial eligibility criteria will be scheduled for a clinic visit to obtain informed consent and to confirm eligibility. Consent will be obtained at the Colorado State University Food and Nutrition Clinical Research Lab (FNCRL) by a screening questionnaire and interview/assessment by the clinical coordinator. After securing consent, eligibility will be confirmed by taking anthropometric measures and participants falling within the BMI range will randomly be assigned to 1 of 3 treatment groups: (1) PreforPro+B. subtilis DE111 probiotic, (2) B. subtilis DE111 alone, or (3) maltodextrin placebo.
Visit 1 (baseline): Eligible individuals will be asked to visit the clinic at visit 1 (baseline) to provide consent and confirm eligibility, undergo sample collections (blood and stool) and analysis procedures (weight/height, hip:waist ratio, gastrointestinal symptoms/ quality of life questionnaires) and receive their stool collection container, a stool log and 3-day diet log. Participants will be schedule for their drop off visit, in which they will return to the clinic 7 days after their first visit (Visit 2, Day 0) to return their stool sample, stool log and 3-day diet record. In return, they will be provided with another stool collection kit, their treatment capsules, another stool log and 3-day diet log. At the end of the 45-day treatment period (Visit 3-Final), final blood and stool samples will be collected as well as additional analyses (such as GI questionnaires, stool logs and 3-day diet record). This means that participants will undergo screening (by phone) and make a total of three (3) visits to the clinic during the study (baseline, Day 0, Final). All blood samples will be collected at Colorado State University by trained personnel. Fecal sample collection will be performed by the study participant with collection materials provided by Colorado State University.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PreforPro+B. subtilis DE111 probiotics | Experimental | Dietary Supplement: PreforPro+B. subtilis DE111 probioticsPreforPro is a prebiotic which is a bacteriophage-based product. This prebiotic was used in combination with Bacillus subtilis probiotics. |
| Placebo(maltodextrin) | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin was used as a placebo. |
| B. subtilis DE111 alone | Active comparator | Dietary Supplement: B. subtilis DE111Bacillus subtilis probiotics was used in this arm alone to compare with the experimental arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Equal numbers of healthy male and female volunteers between 18-75 years old with BMI scores of 18.5 to 34.9.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreforPro+B. subtilis DE111 probioticsPreforPro is bacteriophage-based product which was used in combination with Bacillus subtilis probiotics. | Dietary supplement | PreforPro+B. subtilis DE111 probiotics |
| PlaceboMaltodextrin is rice based powder which was used as placebo. | Dietary supplement | Placebo(maltodextrin) |
| B. subtilis DE111Bacillus subtilis probiotics. | Dietary supplement | B. subtilis DE111 alone |
Primary outcome
Gastrointestinal Health Questionnaire
Time frame: Evaluated at Baseline and Final (52 days apart) with questions designed to capture function from the prior 4 weeks.
Self-assessment of functional measures of gastrointestinal health, including colon and small intestinal pain, gastric function, and gastrointestinal inflammation.
Bowel Movement Diary
Time frame: 52 days
Daily recording of the number and type (based on Bristol Stool chart) of bowel movements.
Quality of Life Assessment
Time frame: Evaluated at Baseline and Final (52 days apart)
Questionnaire that evaluates the impact of gastrointestinal health on daily activities as well as social and psychological impacts.
7 secondary outcomes
Gut microbiota changes (beta-diversity)
Time frame: 2 samples per person, collected ~7 weeks apart
Gut microbiota changes (alpha diversity)
Time frame: 2 samples per person, collected ~7 weeks apart
Intestinal inflammation
Time frame: 2 samples per person, collected ~7 weeks apart
Intestinal inflammation
Time frame: 2 samples per person, collected ~7 weeks apart
Systemic inflammation
Time frame: 2 blood samples per person, collected ~7 weeks apart
Systemic inflammation
Time frame: 2 blood samples per person, collected ~7 weeks apart
Lipid panels
Time frame: 2 blood samples per person, collected ~7 weeks apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 33671071Freedman KE, Hill JL, Wei Y, Vazquez AR, Grubb DS, Trotter RE, Wrigley SD, Johnson SA, Foster MT, Weir TL. Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis DE111. Int J Mol Sci. 2021 Feb 28;22(5):2453. doi: 10.3390/ijms22052453.
- Background: PubMed 32824480Grubb DS, Wrigley SD, Freedman KE, Wei Y, Vazquez AR, Trotter RE, Wallace TC, Johnson SA, Weir TL. PHAGE-2 Study: Supplemental Bacteriophages Extend Bifidobacterium animalis subsp. lactis BL04 Benefits on Gut Health and Microbiota in Healthy Adults. Nutrients. 2020 Aug 17;12(8):2474. doi: 10.3390/nu12082474.
- Background: PubMed 33161737Trotter RE, Vazquez AR, Grubb DS, Freedman KE, Grabos LE, Jones S, Gentile CL, Melby CL, Johnson SA, Weir TL. Bacillus subtilis DE111 intake may improve blood lipids and endothelial function in healthy adults. Benef Microbes. 2020 Nov 15;11(7):621-630. doi: 10.3920/BM2020.0039. Epub 2020 Nov 9.
- Background: PubMed 30157383Gindin M, Febvre HP, Rao S, Wallace TC, Weir TL. Bacteriophage for Gastrointestinal Health (PHAGE) Study: Evaluating the Safety and Tolerability of Supplemental Bacteriophage Consumption. J Am Coll Nutr. 2019 Jan;38(1):68-75. doi: 10.1080/07315724.2018.1483783. Epub 2018 Aug 29.
- Background: PubMed 30897686Febvre HP, Rao S, Gindin M, Goodwin NDM, Finer E, Vivanco JS, Lu S, Manter DK, Wallace TC, Weir TL. PHAGE Study: Effects of Supplemental Bacteriophage Intake on Inflammation and Gut Microbiota in Healthy Adults. Nutrients. 2019 Mar 20;11(3):666. doi: 10.3390/nu11030666.
- Commercial website for phage product used in the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany L Weir, MSc,PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PreforPro+B. subtilis DE111 probiotics and B. subtilis DE111 in people with Gastrointestinal Dysfunction, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Health Questionnaire (time frame: Evaluated at Baseline and Final (52 days apart) with questions designed to capture function from the prior 4 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750433, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.