Gut MicrobiotaNCT07220369
Gut Mini-Pill Study
A study testing plant-based meat alternative entrees, mini-pill and meat based entree in people with Gut Microbiota, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a "mini-pill", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- plant-based meat alternative entrees, mini-pill and meat based entree
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to Aug 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women
- Age >50 to <75 years
- BMI >20 to <35 kg/m2
- Normotensive with or without medication
- Normal gastrointestinal function with regular bowel movements at least once every other day
- Normal kidney and liver function
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- Willingness to swallow the mini-pills
- Willingness to collect and return multiple stool samples
- Adequate refrigerator and freezer space to store study entrées
- Intent to remain in the greater Boston area during the intervention periods
Who cannot join
- Individuals self-reporting adhering to any type of vegetarian diet
- Lack of willingness to restrict fish intake to less than once per week during the dietary intervention phases
- Allergy/intolerance/religious reasons to avoid study foods or food ingredients, including known hypersensitivity to Blue 1 food coloring and wheat gluten.
- Regular use of prebiotics or probiotics within the past 3 months
- Regular use of laxatives or fiber supplements
- Chronic constipation
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- Chronic use of antibiotics (except topical)
- Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists
- Use of dental prophylaxis
- Planned colonoscopy 2 months prior to or during the study period
- Gastroparesis
- Swallowing disorder, or inability or difficulty taking pills
- Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric/ esophageal/intestinal surgery, including lap banding or bariatric surgery.
- History of bowel obstruction, pancreas and liver disorders.
- Any form of active substance abuse or dependence (including drug or alcohol abuse). This information will be stored in REDCAP in a subsection that has no identifiers.
- Established major chronic diseases such as cardiovascular disease, diabetes, active cancer within the last 5 years, or any significant medical condition at the study MD's discretion
- A clinical condition that, in the judgment of the study MD or principal investigator, could potentially pose a health risk to the subject while involved in the study.
- Unwillingness to adhere to study protocol
- Intent to increase or decrease body weight during the study period
- No Social Security number (for payment and IRS forms).
- Individuals who directly report to any member of the research team.
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
Jean Mayer Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
Volunteer Services, 800-738-7555
About this study
Official title: Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling
The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a "mini-pill", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat alternatives). The mini-pills will be recovered in the stool. We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, to better understand the relationship between diet, microbiota and health.
Read the detailed description
The ingestible mini-pill is a non-invasive, single-use, passive collection device that is not intended for diagnosis or treatment. The mini-pills have already been developed, tested and validated by two Tufts researchers, Drs. Sameer Sonkusale (School of Engineering) and Giovanni Widmer (School of Veterinary Medicine), in vitro, ex vitro, and in vivo in animal models (Supplement 1: Research Strategy and Supplement 2: Soft Autonomous Ingestible Device for Sampling the Small Intestinal Microbiome, Del-Rio-Ruiz R et al., manuscript in review). A NSR device designation is being sought from the IRB to conduct a 2-phase randomized-controlled double blind crossover trial in humans by providing two entrées per day containing either meat or plant-based meat alternatives for up to 3 weeks each. After 2 weeks on each diet, participants will consume a provided breakfast meal and then be asked to swallow 6 mini-pills along with a blue food coloring dissolved in 50 mL of water, return home and collect stool samples until all the mini-pills are recovered (varies between 2 and 4 days, but can be up to 6 days). This protocol will allow us to describe the diet-induced progressive change in the GI tract microbiota prior to and including that in the stool.
- Conditions
- Gut Microbiota
- Being tested
- plant-based meat alternative entrees, mini-pill, meat based entree
- Keywords
- gut, mini-pill, gut sampling, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant-based meat alternative entreesOther
2 plant-based meat alternatives per day
mini-pillDevice
mini-pills which sample at different locations in the gut
meat based entreeOther
2 meat based entrees per day
| Study group | Role | What they receive |
|---|---|---|
| Plant-based meat alternative entree | Experimental | Entree that is composed of a plant-based meat alternative Receives: Other: plant-based meat alternative entrees; Device: mini-pill |
| meat entree | Experimental | entree that is composed of meat Receives: Device: mini-pill; Other: meat based entree |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on the gut microbial profile
Using luminal content collected by the gut mini-pill to compare the microbiome and metabolome after subjects consumed a meat-rich and plant-based meat alternative-rich diet
Measured: 8 weeks
Secondary outcomes (1)
Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on cardiometabolic risk factors
Using luminal content collected by the gut mini-pill to compare the cardiometabolic after subjects consumed a meat-rich and plant-based meat alternative-rich diet
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start8 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Lichtenstein, Tufts University
- Investigators
- Alice H Lichtenstein, D.Sc., Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220369
- Sponsor's protocol ID
- 5011
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling
- ClinicalTrials.gov ID
- NCT07220369
- Acronym / sponsor ID
- 5011
- Conditions
- Gut Microbiota
- Keywords
- gut, mini-pill, gut sampling, gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 23 Oct 2025 (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 purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a "mini-pill", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat alternatives). The mini-pills will be recovered in the stool. We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, to better understand the relationship between diet, microbiota and health.
Detailed description
The ingestible mini-pill is a non-invasive, single-use, passive collection device that is not intended for diagnosis or treatment. The mini-pills have already been developed, tested and validated by two Tufts researchers, Drs. Sameer Sonkusale (School of Engineering) and Giovanni Widmer (School of Veterinary Medicine), in vitro, ex vitro, and in vivo in animal models (Supplement 1: Research Strategy and Supplement 2: Soft Autonomous Ingestible Device for Sampling the Small Intestinal Microbiome, Del-Rio-Ruiz R et al., manuscript in review). A NSR device designation is being sought from the IRB to conduct a 2-phase randomized-controlled double blind crossover trial in humans by providing two entrées per day containing either meat or plant-based meat alternatives for up to 3 weeks each. After 2 weeks on each diet, participants will consume a provided breakfast meal and then be asked to swallow 6 mini-pills along with a blue food coloring dissolved in 50 mL of water, return home and collect stool samples until all the mini-pills are recovered (varies between 2 and 4 days, but can be up to 6 days). This protocol will allow us to describe the diet-induced progressive change in the GI tract microbiota prior to and including that in the stool.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-based meat alternative entree | Experimental | Other: plant-based meat alternative entrees, Device: mini-pillEntree that is composed of a plant-based meat alternative |
| meat entree | Experimental | Device: mini-pill, Other: meat based entreeentree that is composed of meat |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and postmenopausal women
- Age >50 to <75 years
- BMI >20 to <35 kg/m2
- Normotensive with or without medication
- Normal gastrointestinal function with regular bowel movements at least once every other day
Key exclusion criteria (21 listed)
- Individuals self-reporting adhering to any type of vegetarian diet
- Lack of willingness to restrict fish intake to less than once per week during the dietary intervention phases
- Allergy/intolerance/religious reasons to avoid study foods or food ingredients, including known hypersensitivity to Blue 1 food coloring and wheat gluten.
- Regular use of prebiotics or probiotics within the past 3 months
- Regular use of laxatives or fiber supplements
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 |
|---|---|---|
| plant-based meat alternative entrees2 plant-based meat alternatives per day | Other | Plant-based meat alternative entree |
| mini-pillmini-pills which sample at different locations in the gut | Device | Plant-based meat alternative entree, meat entree |
| meat based entree2 meat based entrees per day | Other | meat entree |
Primary outcome
Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on the gut microbial profile
Time frame: 8 weeks
Using luminal content collected by the gut mini-pill to compare the microbiome and metabolome after subjects consumed a meat-rich and plant-based meat alternative-rich diet
1 secondary outcome
Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on cardiometabolic risk factors
Time frame: 8 weeks
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 30 Oct 2025.
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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.
Alice H Lichtenstein, D.Sc. principal investigator
Tufts 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 plant-based meat alternative entrees, mini-pill and meat based entree in people with Gut Microbiota, run by Tufts 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 10 inclusion and 21 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 30 Oct 2025. 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. 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 Alice H Lichtenstein, D.Sc. (617 556-3127, alice.lichtenstein@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test feasibility of the mini-pill to characterize differential changes inducted by a meat-rich and plant-based meat alternative-rich diet on the gut microbial profile (time frame: 8 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 30 Oct 2025.