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Die klinische Studie NCT07220369 für Darmmikrobiota ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Gut Mini-Pill Study 30 Biomarker-basiert Ernährung

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07220369 ist eine interventionsstudie zur Untersuchung von Darmmikrobiota und hat den Status offene rekrutierung. Die Studie startete am 8. September 2025 und soll 30 Teilnehmer aufnehmen. Durchgeführt von Tufts University ist der Abschluss für 1. August 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. Oktober 2025 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
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:...Mehr anzeigen
Offizieller Titel

Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling

Erkrankungen
Darmmikrobiota
Weitere Studien-IDs
  • 5011
NCT-Nummer
NCT07220369
Studienbeginn (tatsächlich)
2025-09-08
Zuletzt aktualisiert
2025-10-30
Studienende (vorauss.)
2028-08
Geplante Rekrutierung
30
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
gut
mini-pill
gut sampling
gut microbiota
Primäres Ziel
Machbarkeitsprüfung für Medizinprodukte
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Dreifach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellPlant-based meat alternative entree
Entree that is composed of a plant-based meat alternative
plant-based meat alternative entrees
2 plant-based meat alternatives per day
mini-pill
mini-pills which sample at different locations in the gut
Experimentellmeat entree
entree that is composed of meat
mini-pill
mini-pills which sample at different locations in the gut
meat based entree
2 meat based entrees per day
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
8 weeks
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
8 weeks
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
50 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • 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

  • 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.
Tufts University logoTufts University
Verantwortliche Partei
Alice Lichtenstein, Hauptprüfer, Director of Cardiovascular Research Team, Tufts University
Zentrale Studienkontakte
Kontakt: Alice H Lichtenstein, D.Sc., 617 556-3127, [email protected]
Kontakt: Jean Galluccio, BS, 617 556-3121, [email protected]
1 Studienstandorte in 1 Ländern

Massachusetts

Jean Mayer Human Nutrition Research Center on Aging, Boston, Massachusetts, 02111, United States
Volunteer Services, Kontakt, 800-738-7555
Offene Rekrutierung