- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037295
Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85014
- NIDDK, Phoenix
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Free of acute and chronic diseases (especially GI disorders) as determined by medical history, physical examination and laboratory tests.
Individuals may be taking laxative drugs but they must be discontinued 3 or more weeks before admission.
Age 18-45 y (in order to minimize the affect of aging on nutrient absorption).
EXCLUSION CRITERIA:
Because it is unclear how chronic illnesses or substance abuse could affect nutrient absorption we will exclude volunteers with chronic diseases or current substance abuse. This is especially important because the limited number of study subjects in this study will make it hard to control for these confounders. We will therefore exclude subjects with a history or clinical manifestation of:
- Current smoking
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo- and hyperthyroidism
- HIV infection (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV
- Active tuberculosis (self-report)
- Asthma on active daily treatment with medications
- Pulmonary disorders including physician diagnosed chronic obstructive pulmonary diseases and obstructive sleep apnea syndrome
- Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
- Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) and irritable bowel syndrome.
- Lactose intolerance
- Anemia (defined as hemoglobin < 11 mg/dl), leucopenia (defined as white blood cell count < 4,000/microL) or thrombocytopenia (defined as platelet count < 150,000/microL)
- Liver disease, including non-alcoholic fatty liver disease or current elevated liver enzymes over 1.5 times the normal range for AST, ALT or GGT or a history and physical exam that indicates a potential liver disease as describe by Giannini et al
- Evidence of chronic renal disease as defined by estimated glomerular filtration rate of < 60 ml/min or evidence of overt proteinuria on urine dipstick.
- Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis
- Behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as major depression, schizophrenia and presence of psychotic symptoms)
- Eating disorders such as anorexia nervosa, bulimia or binge eating syndrome
- Taking weight loss drugs
- Weight change of more than 5% of total body weight in the 3 months before admission
- Use of any antibiotic or probiotic agents within 6 months prior to minimize the potential effects of these substances on the gut microbiota.
- Use of antacids (Proton pump inhibitors, H2 antagonists or aluminum/magnesium hydroxide) 3 months prior to the study assessed by self-report because a modified gastric pH might affect the gut microbiota as well
- Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana)
The following exclusion criteria are necessary because of the substances given or tests performed during the study
- Known allergies to vancomycin
- Known allergies to heparin or a history of heparin-induced thrombocytopenia
- Personal history or evidence of a bleeding disorder
All individuals will be fully informed of the aim, nature, and risks of the study prior to giving written informed consent. The study s informed consent will be obtained by a principal or associate investigator, research physician or physician assistant working in the clinical research unit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OF_UF Vancomycin
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin
|
Vancomycin 125mg orally four times per day for 12 days
Diet in which the calories are 150% of their weight maintaining energy requirements
Diet in which the calories are 50% of their weight maintaining energy requirements
|
Placebo Comparator: OF_UF Placebo
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo
|
Diet in which the calories are 150% of their weight maintaining energy requirements
Diet in which the calories are 50% of their weight maintaining energy requirements
Placebo pills orally four times per day for 12 days
|
Experimental: UF_OF Vancomycin
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin
|
Vancomycin 125mg orally four times per day for 12 days
Diet in which the calories are 150% of their weight maintaining energy requirements
Diet in which the calories are 50% of their weight maintaining energy requirements
|
Placebo Comparator: UF_OF Placebo
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo
|
Diet in which the calories are 150% of their weight maintaining energy requirements
Diet in which the calories are 50% of their weight maintaining energy requirements
Placebo pills orally four times per day for 12 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stool Calories During OF and UF
Time Frame: Days 5-7 and 11-13
|
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day)
|
Days 5-7 and 11-13
|
Stool Calories During Vancomycin and Placebo
Time Frame: Days 23-25
|
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day), vancomycin compared to placebo
|
Days 23-25
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine Calories During OF and UF
Time Frame: Days 5-7 and 11-13
|
Calculated as urine calories (kcal/day) x 100/ingested calories (kcal/day)
|
Days 5-7 and 11-13
|
Urine Calories During Vancomycin and Placebo
Time Frame: Days 23-25
|
Calculated as urine calories (kcal/day) x 100/ingested calories (kcal/day), vancomycin compared to placebo
|
Days 23-25
|
Change in 2 Hour Glucose Tolerance From Day 16 to Day 28 During Vancomycin and Placebo
Time Frame: Day 16 and day 28
|
A 75-g 2 hour oral glucose tolerance test (OGTT) was performed on days 16 and 28, before and after treatment with vancomycin or placebo.
|
Day 16 and day 28
|
Overall Gut Microbial Colonization During OF and UF
Time Frame: Days 5-7 and 11-13
|
qPCR-based quantification of 16S rRNA gene copies per gram wet weight (log10)
|
Days 5-7 and 11-13
|
Overall Gut Microbial Colonization During Vancomycin and Placebo
Time Frame: Days 23-25
|
qPCR-based quantification of 16S rRNA gene copies per gram wet weight (log10)
|
Days 23-25
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Yanovski SZ, Yanovski JA. Obesity. N Engl J Med. 2002 Feb 21;346(8):591-602. doi: 10.1056/NEJMra012586. No abstract available.
- Basolo A, Parrington S, Ando T, Hollstein T, Piaggi P, Krakoff J. Procedures for Measuring Excreted and Ingested Calories to Assess Nutrient Absorption Using Bomb Calorimetry. Obesity (Silver Spring). 2020 Dec;28(12):2315-2322. doi: 10.1002/oby.22965. Epub 2020 Oct 7.
- Segal KR, Dunaif A. Resting metabolic rate and postprandial thermogenesis in polycystic ovarian syndrome. Int J Obes. 1990 Jul;14(7):559-67.
- Weststrate JA, Dekker J, Stoel M, Begheijn L, Deurenberg P, Hautvast JG. Resting energy expenditure in women: impact of obesity and body-fat distribution. Metabolism. 1990 Jan;39(1):11-7. doi: 10.1016/0026-0495(90)90141-x.
- Basolo A, Hohenadel M, Ang QY, Piaggi P, Heinitz S, Walter M, Walter P, Parrington S, Trinidad DD, von Schwartzenberg RJ, Turnbaugh PJ, Krakoff J. Effects of underfeeding and oral vancomycin on gut microbiome and nutrient absorption in humans. Nat Med. 2020 Apr;26(4):589-598. doi: 10.1038/s41591-020-0801-z. Epub 2020 Mar 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999914045
- 14-DK-N045 (Other Identifier: NIDDK)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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