๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2021-12-12

Probiotics and Gut Health (NCT03418857)

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Penn State University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study evaluates the effects of probiotic consumption on inflammatory outcomes and measures of gut health. Participants will be given yogurt with probiotics for one period and yogurt without probiotics for another, with a break in between. These periods will occur in random order.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (14 items).

Location: The Pennsylvania State University โ€” University Park, Pennsylvania

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • allergy to dairy
  • smoking and/or use of tobacco products
  • systolic blood pressure โ‰ฅ 160 mmHg
  • diastolic blood pressure \> 100 mmHg
  • fasting glucose โ‰ฅ 126 mg/dL
  • history of myocardial infarction, cardiovascular disease (CVD), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication)
  • use of cholesterol or lipid lowering medications
  • use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods)
  • refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics
  • clinical diagnosis of inflammatory bowel disease (IBD) e.g. Chron's disease or ulcerative colitis
  • Use of antibiotics within the last 2 months

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • The Pennsylvania State University โ€” University Park, Pennsylvania

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—