Gastrointestinal SymptomsPhage-CLEARNCT07816809
Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience
A study testing Bacteriophages - MuniPhage and Bacteriophages - RenuPhage in people with Gastrointestinal Symptoms and Skin Quality, run by Colorado State University at 1 site in United States.
Trial summary
Bacteriophages are viruses that can selectively infect specific species and strains of bacteria. Some bacterial species in the human gut have been negatively associated with gut health and skin health. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms, Skin Quality
- What is being tested?
- Bacteriophages - MuniPhage and Bacteriophages - RenuPhage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Between 18-75 years old
- BMI <30
- Experiencing mild-moderate gastrointestinal distress/ abdominal pain, bloating, constipation, and/or diarrhea
Who cannot join
- Younger than 18 years old or greater than 75 years old
- BMI >29.9
- Antibiotic use in the past 2 months
- Use of statins, metformin, prescription NSAIDs, and MAO inhibitors, or other medications that could interfere with study outcomes, as determined by the study PI
- Current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, or cardiometabolic disease (diabetes, cardiovascular disease)
- Individuals with allergies to capsule ingredients
Show all 12Show fewer
- Pregnant or breastfeeding individuals
- Excess alcohol consumption (≥4 drinks on any given occasion and/or ≥8 drinks/week for women, and ≥5 drinks on any given occasion and/or ≥15 drinks/week for men)
- Use of dietary supplements that contain probiotics or phages
- Actively trying to lose weight
- Participation in other research studies that would interfere with study endpoints or compliance
- Unable or unwilling to consume capsules, provide stool or blood samples, track bowel movements and symptoms, and attend scheduled clinic visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Colorado State University
Fort Collins, Colorado, 80523
Tiffany Weir, PhD, 970-215-7571, tiffany.weir@colostate.edu
Tiffany Weir, PhD
About this study
Official title: Phage-CLEAR: Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience
Bacteriophages are viruses that can selectively infect specific species and strains of bacteria. Some bacterial species in the human gut have been negatively associated with gut health and skin health. This study is designed to measure the efficacy of two different bacteriophage-based treatments for 4 weeks to improve gut and skin health. These treatments are bacteriophage that target specific strains of Escherichia coli and Staphylococcus Aureus.
- Conditions
- Gastrointestinal Symptoms, Skin Quality
- Being tested
- Bacteriophages - MuniPhage, Bacteriophages - RenuPhage, Placebo
- Keywords
- Gut Health, Skin Health, Bacteriophage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophages - MuniPhageDietary supplement
Also called MuniPhage
1 x 106 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95
Bacteriophages - RenuPhageDietary supplement
Also called RenuPhage
1 x 106 PFU of phage strains LG91, BD117, CD007, and PD23
PlaceboOther
Rice maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| MuniPhage | Experimental | 1 x 10E6 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95 that have been designed to target specific pro-inflammatory E. coli strains in the gut. Receives: Dietary Supplement: Bacteriophages - MuniPhage |
| RenuPhage | Experimental | Dietary supplement containing 1 x 10E6 PFU of phage strains LG91, BD117, CD007, and PD23 designed to target S. aureus in the gut which may also reduce S. aureus load on the skin. Receives: Dietary Supplement: Bacteriophages - RenuPhage |
| Placebo | Placebo comparator | Rice maltodextrin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale
The Gastrointestinal Symptom Rating Scale (GSRS) is a widely used tool for measuring gastrointestinal symptoms across five domains. The GSRS is scored between "No discomfort" and "Very severe discomfort"
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
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 Weir, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816809
- Sponsor's protocol ID
- 7927
- Acronym
- Phage-CLEAR
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phage-CLEAR: Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience
- ClinicalTrials.gov ID
- NCT07816809
- Acronym / sponsor ID
- Phage-CLEAR / 7927
- Conditions
- Gastrointestinal Symptoms, Skin Quality
- Keywords
- Gut Health, Skin Health, Bacteriophage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Sep 2026 (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.
Bacteriophages are viruses that can selectively infect specific species and strains of bacteria. Some bacterial species in the human gut have been negatively associated with gut health and skin health. This study is designed to measure the efficacy of two different bacteriophage-based treatments for 4 weeks to improve gut and skin health. These treatments are bacteriophage that target specific strains of Escherichia coli and Staphylococcus Aureus.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MuniPhage | Experimental | Dietary Supplement: Bacteriophages - MuniPhage1 x 10E6 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95 that have been designed to target specific pro-inflammatory E. coli strains in the gut. |
| RenuPhage | Experimental | Dietary Supplement: Bacteriophages - RenuPhageDietary supplement containing 1 x 10E6 PFU of phage strains LG91, BD117, CD007, and PD23 designed to target S. aureus in the gut which may also reduce S. aureus load on the skin. |
| Placebo | Placebo comparator | Other: PlaceboRice maltodextrin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18-75 years old
- BMI <30
- Experiencing mild-moderate gastrointestinal distress/ abdominal pain, bloating, constipation, and/or diarrhea
Key exclusion criteria (12 listed)
- Younger than 18 years old or greater than 75 years old
- BMI >29.9
- Antibiotic use in the past 2 months
- Use of statins, metformin, prescription NSAIDs, and MAO inhibitors, or other medications that could interfere with study outcomes, as determined by the study PI
- Current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, or cardiometabolic disease (diabetes, cardiovascular disease)
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 |
|---|---|---|
| Bacteriophages - MuniPhageAlso: MuniPhage1 x 106 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95 | Dietary supplement | MuniPhage |
| Bacteriophages - RenuPhageAlso: RenuPhage1 x 106 PFU of phage strains LG91, BD117, CD007, and PD23 | Dietary supplement | RenuPhage |
| PlaceboRice maltodextrin | Other | Placebo |
Primary outcome
Gastrointestinal Symptom Rating Scale
Time frame: 4 weeks
The Gastrointestinal Symptom Rating Scale (GSRS) is a widely used tool for measuring gastrointestinal symptoms across five domains. The GSRS is scored between "No discomfort" and "Very severe discomfort"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Tiffany 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 Bacteriophages - MuniPhage and Bacteriophages - RenuPhage in people with Gastrointestinal Symptoms and Skin Quality, 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 12 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Weir, PhD (970-215-7571, tiffany.weir@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Rating Scale (time frame: 4 weeks). 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 8 Oct 2026.