Mini-Pill for Gut Microbiome

Overseen By Jean Galluccio, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must not be taking: Prebiotics, Probiotics, Laxatives, others

Disqualifiers: Vegetarian diet, Chronic constipation, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to study how different diets affect the gut microbiome (the community of bacteria in the digestive system) and overall health. Participants will swallow a mini-pill, a small device that collects samples from the gut after consuming meals with either meat or plant-based meat alternatives. Researchers will analyze these samples to understand how diet influences gut bacteria and health markers related to heart and metabolic health. The trial seeks men and postmenopausal women over 50 with regular digestion who are willing to participate in sample collection. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and gut health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it excludes those who regularly use certain medications like antibiotics, stomach acid reducers, and weight loss drugs. It's best to discuss your specific medications with the study team.

What prior data suggests that this mini-pill is safe for collecting GI samples?

Research shows that the mini-pill used in this study is a new tool for collecting samples from the gut. Direct safety information for this specific mini-pill is limited. The study is in an early stage, focusing more on exploring new ideas than on proving safety and effectiveness. This often means the treatment has not yet been confirmed as safe for people.

The mini-pill is designed to be noninvasive, moving through the digestive system naturally, like food. This design suggests it might be easy for the body to handle, but without specific data, certainty is lacking. Prospective participants should ask questions and discuss any concerns with the study team to understand the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mini-Pill for Gut Microbiome because it offers a novel approach to influencing gut health. Unlike traditional treatments that might involve dietary changes or probiotics, this mini-pill aims to directly modulate the gut microbiome in a precise manner. The trial also explores the effects of different dietary components, comparing meat-based and plant-based meat alternative entrees, which could shed light on how these diets impact gut bacteria. This comprehensive approach could lead to more effective and personalized ways to manage gut-related health issues, something current options don't fully address.

What evidence suggests that this mini-pill is effective for collecting GI samples?

Research has shown that the mini-pill might be useful for collecting samples from the gut to study the microbiome. This small device travels through the digestive system and gathers samples from different areas. In this trial, participants will consume either a meat entree or a plant-based meat alternative entree to help researchers learn how these different diets impact gut bacteria. Although direct evidence on its effectiveness is not yet available, the mini-pill's ability to gather samples could offer important insights into the connections between diet, gut bacteria, and overall health. This noninvasive method, which avoids surgery or similar procedures, provides a more comfortable and safer option. ^{1 2 4 5 6}

Who Is on the Research Team?

Alice H Lichtenstein, D.Sc.

Principal Investigator

Tufts University

Are You a Good Fit for This Trial?

This trial is for individuals interested in how different diets affect their gut health. Participants should be willing to consume both meat-based and plant-based meals, as well as swallow a 'mini-pill' that collects gut samples. Specific eligibility criteria are not provided.

Inclusion Criteria

BMI >20 to <35 kg/m2

Willingness to swallow the mini-pills

Willingness to collect and return multiple stool samples

Exclusion Criteria

Individuals self-reporting adhering to any type of vegetarian diet

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants consume two entrées per day containing either meat or plant-based meat alternatives for up to 3 weeks each

6 weeks

Participants consume meals at home

Sample Collection

Participants consume a provided breakfast meal, swallow 6 mini-pills, and collect stool samples until all mini-pills are recovered

2-6 days

Home-based sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mini-Pill

Trial Overview The study tests an ingestible 'mini-pill' designed to sample the gut's contents after eating meat or plant-based meals. The goal is to analyze these samples along with stool and blood biomarkers related to heart health and metabolism.

How Is the Trial Designed?

Group I: meat entree Experimental Treatment 2 Interventions

entree that is composed of meat

Group II: Plant-based meat alternative entree Experimental Treatment 2 Interventions

Entree that is composed of a plant-based meat alternative

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220369

Study Details | NCT07220369 | Gut Mini-Pill Study The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a "mini-pill", can collect ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12034237/

Estrogen-Gut-Brain Axis: Examining the Role of Combined ... Combined oral contraceptives (COCs) possess the ability to alter the normal composition of the gut microbiome and the permeability of the ...

3. journals.physiology.org journals.physiology.org/doi/pdf/10.1152/japplphysiol.00008.2025

Hormonal birth control is associated with altered gut ... We hypothesized that there would be no significant effects of hormonal contraception or menstrual cycle time point on gut microbiota diversity ...

4. frontiersin.org frontiersin.org/journals/microbiomes/articles/10.3389/frmbi.2022.1055472/full

The impact of contraceptives on the vaginal microbiome in ... There is minimal data on the effect of progesterone-only-pills (POP or 'mini-pill') on the vaginal microbiome, but some research has ...

5. withpower.com withpower.com/trial/phase-gut-microbiota-8-2025-9d6fd

Mini-Pill for Gut Microbiome We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, ...

6. biocodexmicrobiotainstitute.com biocodexmicrobiotainstitute.com/en/impact-contraceptives-microbiota-hit-and-miss

The impact of contraceptives on the microbiota? Hit and miss! However, the pill artificially maintains constant levels of estrogen and progesterone in the blood, which appears to disturb the gut microbiota.