Dietary Strategies to Restore Gut Microbiota Diversity of Americans: Fiber vs Probiotics



Status:Completed
Conditions:Infectious Disease, Endocrine
Therapuetic Areas:Endocrinology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/19/2018
Start Date:August 29, 2016
End Date:June 2, 2017

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The primary objective is to contrast the degree to which increased consumption of dietary
fiber vs. probiotics can increase microbiota diversity and can impact microbiota production
of short-chain fatty acids (SCFA), potential normalizers of metabolic and immune dysfunction,
in obese and non-obese adults.

The centrality of the gut microbiota to human health has emerged in just the last decade,
with the last three years implicating our modern, deteriorated gut microbiota in numerous
chronic diseases. It is likely dietary changes in the last half-century consistent with
adoption of the Western diet have had an adverse impact on the gut microbiota. A critically
important next step in this field of research is to identify how different probiotic
supplements can potentially restore the microbiota in alignment with the optimization of
human health, particularly in regards to the reversal or prevention of chronic diseases
including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed
to elicit and contrast the amount of increase in microbiota diversity and related metabolic
output achievable by several distinctly different dietary approaches commonly available to
the general population. The results could contribute to dietary recommendations for reversing
the chronic disease epidemics of westernization.

Inclusion Criteria:

- 18 and older, both genders, all ethnic backgrounds

- Healthy subjects willing and able to provide blood, as well as stool specimens

- Able to provide signed and dated informed consent.

Exclusion Criteria:

- Body Mass Index higher than 40.

- Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure
greater than 160/100, oral temperature greater than 100 degrees F, pulse greater than
100.

- Use of any of the following drugs within the last 6 months:

1. systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous,
intramuscular, or oral);

2. oral, intravenous, intramuscular, nasal or inhaled corticosteroids;

3. cytokines;

4. methotrexate or immunosuppressive cytotoxic agents;

5. large doses of commercial probiotics consumed (greater than or equal to 108 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 (defer sampling until subject recovers). Acute
disease is defined as the presence of a moderate or severe illness with or without
fever.

- Chronic, clinically significant (unresolved, requiring on-going medical management or
medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional
abnormality, as determined by medical history or physical examination.

- History of cancer 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 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.

- Positive test for HIV, HBV or HCV.

- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (
primary or acquired) including HIV infection.

- Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy,
in the past five years. Any major bowel resection at any time.

- History of active uncontrolled gastrointestinal disorders or diseases including:

1. inflammatory bowel disease (IBD) including ulcerative colitis
(mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate
colitis;

2. irritable bowel syndrome (IBS) (moderate-severe);

3. persistent, infectious gastroenteritis, colitis or gastritis, persistent or
chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent)
or Helicobacter pylori infection (untreated);

4. chronic constipation.

Female who is pregnant or lactating.
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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from
Stanford, CA
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