The RAMP Study - Rejuvenation of the Aging Microbiota With Prebiotics (RAMP)

This is an interventional prevention trial for Microbiome Read More

Inclusion Criteria:

• 60 years old and older
• Otherwise, healthy subjects willing and able to provide blood as well as stool specimens
• Must be able to provide signed and dated informed consent and be willing to follow protocol

Exclusion Criteria:

• Body Mass Index >= 40
• LDL-C > 190 mg/dL
• Systolic Blood Pressure >160 mmHg OR Diastolic Blood Pressure > 90 mmHg

• Use of any of the following drugs/supplements within the last 2 months:

  • systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
  • corticosteroids (intravenous, intramuscular, oral, nasal or inhaled)
  • cytokines
  • methotrexate or immunosuppressive cytotoxic agents
  • metformin
  • proton pump inhibitors (PPIs)

• Regular use of any of the following medications:

  • regular dose aspirin (>81mg/day)
  • opiate pain medication
• Use of large doses of commercial probiotics consumed (greater than or equal to 10-8 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
• Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Examples include flu or gastroenteritis. Defer sampling until subject recover.
• Chronic, clinically significant, unstable (unresolved, requiring on-going changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history. Type 2 diabetes, type 1 diabetes, and dialysis will be excluded.

• History of active uncontrolled gastrointestinal disorders or diseases including:

  • inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
  • irritable bowel syndrome (IBS) (moderate-severe);
  • persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).
• History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
• Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
• Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or > 14 drinks/week.
• Positive test for HIV, HBV or HCV.
• Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.
• Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
• Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products.
• Any confirmed or suspected autoimmune disease. Examples include multiple sclerosis and Graves disease.
• Veganism.
• Dairy allergies.