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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT03690999
Impact of a Prebiotic Supplement on Microbiome, Immune System, and Metabolic Status of Older Adults
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.
dietary supplement: Placebo
dietary supplement: Prebiotic supplement
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Robinson, PhD
650-736-8577