Mild Gastrointestinal Symptoms in Healthy AdultsPHAGE2NCT04511221
BacterioPHAGE for Gastrointestinal Health 2 Study
A study testing Bifidobacterium animals subsp. lactis BL04+PreforPro and Bifidobacterium animals subsp. lactis BL04 in people with Mild Gastrointestinal Symptoms in Healthy Adults, run by Colorado State University at 1 site in United States.
Trial summary
The BacterioPHAGE for Gastrointestinal Health-2 study is designed to determine if a commercial bacteriophage product can increase the survival and efficacy of probiotic bacteria that will be concurrently administered. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Gastrointestinal Symptoms in Healthy Adults
- What is being tested?
- Bifidobacterium animals subsp. lactis BL04+PreforPro and Bifidobacterium animals subsp. lactis BL04
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Mar 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- 18-65 years old
- BMI 20 to 34.9
Who cannot join
- individuals less than 18 years of age or greater than 65 years of age
- outside of the BMI range of 20-34.9
- antibiotic or probiotic/prebiotic supplements within two months of the start of treatment
- use of statins, metformin, NSAIDs, MAO inhibitors, and botanical supplements that target the GI tract or gut microbiota
- current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and metabolic disorders
- pregnant and breastfeeding women
- unable to adhere to the study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523-1571
About this study
The BacterioPHAGE for Gastrointestinal Health-2 study is designed to determine if a commercial bacteriophage product can increase the survival and efficacy of probiotic bacteria that will be concurrently administered. Bacteriophages may act as prebiotics, which are traditionally defined as indigestible dietary components that selectively enhance specific bacterial species in the intestines to confer a health benefit. In this study, the "prebiotic" is a unique combination of bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe for human consumption and are presumed to function by infecting pro-inflammatory E. coli strains in the gut. The removal of these strains alters the gut environment to allow growth of more favorable bacteria, and the lysis products of these E. coli may be assimilated by beneficial species to enhance their populations.The phage product, PreforPro, has shown to be effective in culture-based and animal studies, but its efficacy in increasing specific probiotic species has not been demonstrated in humans. The investigators 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.
Read the detailed description
The commercial bacteriophage preparation,PreforPro, is often found as an ingredient in commercial probiotcs, so the goal of the current study is to determine if PreforPro consumption concurrent with probiotic usage improves probiotic survival and activity. A secondary goal of this study is to assess various physiologic parameters to determine whether consumption of PreforPro with a probiotic offers any health benefits beyond those of consuming a probiotic alone. The investigators will examine whether consumption of the PreforPro product increases detectable numbers of co-consumed probiotics and improves parameters in clinical outcomes related to glucose and lipid metabolism, cardiovascular function, inflammation of the intestines, or physical symptoms of gastrointestinal distress.
To accomplish these research goals, the investigators will be seeking 200 male and female volunteers between 18-65 years old with BMI scores of 22 to 34.9. Recruitment will be by referral from local practitioners, email recruitment, and through word-of-mouth. Eligibility will be determined at the Colorado State University Food and Nutrition Clinical Research lab 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+Bifidobacterium probiotic, (2) Bifidobacterium probiotic alone, or (3) placebo. Participants will consume the provided capsules daily for a period of four (4) weeks. Participants will be asked to visit the clinic at Visit 1 (Day 0) to pick up their supply of capsules and undergo sample collections (blood and stool) and analysis procedures, including weight/height, blood pressure, endothelial function analysis, gastrointestinal symptom screening, and blood and stool sample collection. At the end of the 4 week treatment period, all analyses will be repeated. This means that participants will undergo screening (either in person or by phone) and make a total of two (2) clinic visits during the study (baseline, and final visit). Participants will additionally be asked to complete two 24 hour dietary recalls prior to each clinic visit and track bowel movements using the Bristol Stool Scale throughout the study treatment period. 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.
- Being tested
- Bifidobacterium animals subsp. lactis BL04+PreforPro, Bifidobacterium animals subsp. lactis BL04, Placebo
- Keywords
- gastrointestinal, probiotic, bacteriophage, Bifidobacterium animalis subspecies lactis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animals subsp. lactis BL04+PreforProDietary supplement
One 15mg capsule taken orally each day
Bifidobacterium animals subsp. lactis BL04Dietary supplement
One 15mg capsule taken orally each day
PlaceboOther
One 15mg capsule taken orally each day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 15 mg capsule containing rice maltodextrin and medium chain coconut triglycerides Receives: Other: Placebo |
| Bifidobacterium animals subsp. lactis BL04 | Active comparator | 15 mg capsule containing 1x 10^9 CFU Bifidobacterium animals subsp. lactis BL04 with rice maltodextrin and medium chain coconut triglycerides as a filler material Receives: Dietary Supplement: Bifidobacterium animals subsp. lactis BL04 |
| Bifidobacterium animals subsp. lactis BL04+PreforPro | Experimental | 15 mg capsule containing 1x 10^9 CFU Bifidobacterium animals subsp. lactis BL04 and 1x10^6 PFU of PreforPro (Commercial phage preparation) with rice maltodextrin and medium chain coconut triglycerides as a filler material Receives: Dietary Supplement: Bifidobacterium animals subsp. lactis BL04+PreforPro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptoms
A functional gastrointestinal questionnaire was used to assess pain and symptoms related to GI function, GI inflammation, Colon and small intestine pain
Measured: Four weeks
Bowel Function
A record of all stools (using Bristol Stool Scale) was collected throughout the study
Measured: Four weeks
Microbiota Analysis
16s sequencing and phage plating was conducted to assess phage activity and microbiota associated changes.
Measured: Four weeks
Secondary outcomes (4)
Blood pressure
Blood pressure will be measured on non-dominant arm using a Sphygmacor. Three consecutive measures will be taken after particioants have spent 5 minutes in a supine position.
Measured: Four weeks
Endothelial Function
Endothelial function will be measured using EndoPat technology and expressed as Reactive Hyperemia Index (RHI)
Measured: Four Weeks
Plasma Lipids
A single venous blood sample will be collected and 200 ul added to a Piccolo test
cartridge for Plasma lipids, which measures total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. Additionally these measures are used to calculate TC/HDL ratio.
Measured: Four weeks
Comprehensive Metabolic Panel
A single venous blood sample will be collected and 200 ul added to a Piccolo test cartridge that measures glucose, creatinine, creatine kinase, blood urea nitrogen (BUN), total carbon dioxide, and chloride, sodium and potassium ions.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Oct 2018
- Primary completion31 Oct 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Gastrointestinal Symptoms in Healthy AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo controlled, parallel arm
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany Weir, Colorado State University
- Investigators
- Tiffany L Weir, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511221
- Sponsor's protocol ID
- 19-9145H
- Acronym
- PHAGE2
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BacterioPHAGE for Gastrointestinal Health 2 Study
- ClinicalTrials.gov ID
- NCT04511221
- Acronym / sponsor ID
- PHAGE2 / 19-9145H
- Keywords
- gastrointestinal, probiotic, bacteriophage, Bifidobacterium animalis subspecies lactis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Aug 2020 (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 BacterioPHAGE for Gastrointestinal Health-2 study is designed to determine if a commercial bacteriophage product can increase the survival and efficacy of probiotic bacteria that will be concurrently administered. Bacteriophages may act as prebiotics, which are traditionally defined as indigestible dietary components that selectively enhance specific bacterial species in the intestines to confer a health benefit. In this study, the "prebiotic" is a unique combination of bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe for human consumption and are presumed to function by infecting pro-inflammatory E. coli strains in the gut. The removal of these strains alters the gut environment to allow growth of more favorable bacteria, and the lysis products of these E. coli may be assimilated by beneficial species to enhance their populations.The phage product, PreforPro, has shown to be effective in culture-based and animal studies, but its efficacy in increasing specific probiotic species has not been demonstrated in humans. The investigators 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.
Detailed description
The commercial bacteriophage preparation,PreforPro, is often found as an ingredient in commercial probiotcs, so the goal of the current study is to determine if PreforPro consumption concurrent with probiotic usage improves probiotic survival and activity. A secondary goal of this study is to assess various physiologic parameters to determine whether consumption of PreforPro with a probiotic offers any health benefits beyond those of consuming a probiotic alone. The investigators will examine whether consumption of the PreforPro product increases detectable numbers of co-consumed probiotics and improves parameters in clinical outcomes related to glucose and lipid metabolism, cardiovascular function, inflammation of the intestines, or physical symptoms of gastrointestinal distress.
To accomplish these research goals, the investigators will be seeking 200 male and female volunteers between 18-65 years old with BMI scores of 22 to 34.9. Recruitment will be by referral from local practitioners, email recruitment, and through word-of-mouth. Eligibility will be determined at the Colorado State University Food and Nutrition Clinical Research lab 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+Bifidobacterium probiotic, (2) Bifidobacterium probiotic alone, or (3) placebo. Participants will consume the provided capsules daily for a period of four (4) weeks. Participants will be asked to visit the clinic at Visit 1 (Day 0) to pick up their supply of capsules and undergo sample collections (blood and stool) and analysis procedures, including weight/height, blood pressure, endothelial function analysis, gastrointestinal symptom screening, and blood and stool sample collection. At the end of the 4 week treatment period, all analyses will be repeated. This means that participants will undergo screening (either in person or by phone) and make a total of two (2) clinic visits during the study (baseline, and final visit). Participants will additionally be asked to complete two 24 hour dietary recalls prior to each clinic visit and track bowel movements using the Bristol Stool Scale throughout the study treatment period. 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blinded, placebo controlled, parallel arm
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo15 mg capsule containing rice maltodextrin and medium chain coconut triglycerides |
| Bifidobacterium animals subsp. lactis BL04 | Active comparator | Dietary Supplement: Bifidobacterium animals subsp. lactis BL0415 mg capsule containing 1x 10^9 CFU Bifidobacterium animals subsp. lactis BL04 with rice maltodextrin and medium chain coconut triglycerides as a filler material |
| Bifidobacterium animals subsp. lactis BL04+PreforPro | Experimental | Dietary Supplement: Bifidobacterium animals subsp. lactis BL04+PreforPro15 mg capsule containing 1x 10^9 CFU Bifidobacterium animals subsp. lactis BL04 and 1x10^6 PFU of PreforPro (Commercial phage preparation) with rice maltodextrin and medium chain coconut triglycerides as a filler material |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy
- 18-65 years old
- BMI 20 to 34.9
Key exclusion criteria (7 listed)
- individuals less than 18 years of age or greater than 65 years of age
- outside of the BMI range of 20-34.9
- antibiotic or probiotic/prebiotic supplements within two months of the start of treatment
- use of statins, metformin, NSAIDs, MAO inhibitors, and botanical supplements that target the GI tract or gut microbiota
- current diagnosis of 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 |
|---|---|---|
| Bifidobacterium animals subsp. lactis BL04+PreforProOne 15mg capsule taken orally each day | Dietary supplement | Bifidobacterium animals subsp. lactis BL04+PreforPro |
| Bifidobacterium animals subsp. lactis BL04One 15mg capsule taken orally each day | Dietary supplement | Bifidobacterium animals subsp. lactis BL04 |
| PlaceboOne 15mg capsule taken orally each day | Other | Placebo |
Primary outcome
Gastrointestinal Symptoms
Time frame: Four weeks
A functional gastrointestinal questionnaire was used to assess pain and symptoms related to GI function, GI inflammation, Colon and small intestine pain
Bowel Function
Time frame: Four weeks
A record of all stools (using Bristol Stool Scale) was collected throughout the study
Microbiota Analysis
Time frame: Four weeks
16s sequencing and phage plating was conducted to assess phage activity and microbiota associated changes.
4 secondary outcomes
Blood pressure
Time frame: Four weeks
Endothelial Function
Time frame: Four Weeks
Plasma Lipids
Time frame: Four weeks
Comprehensive Metabolic Panel
Time frame: Four weeks
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 13 Aug 2020.
- Individual participant dataSharing planned: No
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, 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 Bifidobacterium animals subsp. lactis BL04+PreforPro and Bifidobacterium animals subsp. lactis BL04 in people with Mild Gastrointestinal Symptoms in Healthy Adults, 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 3 inclusion and 7 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 13 Aug 2020. 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 Symptoms (time frame: Four 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?
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 13 Aug 2020.