Status:
RECRUITING
Gut Mini-Pill Study
Lead Sponsor:
Tufts University
Conditions:
Gut Microbiota
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief 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 differe...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07220369
Start Date
September 8 2025
End Date
August 1 2028
Last Update
October 30 2025
Active Locations (1)
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1
Jean Mayer Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111