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Longitudinal Study of the Human Intestinal Microbiome

Primary Purpose

Dysbacteriosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ciprofloxacin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dysbacteriosis focused on measuring genomic techniques, intestinal microbiome

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-Male or female, ages 18 to 45 years, inclusive. -Healthy as determined by screening medical history, medication history, and absence of acute illness such as gastrointestinal or respiratory infection. -Capable of understanding, consenting and complying with the entire study protocol. -Provide voluntary written Informed Consent. -Females of childbearing potential are required to utilize an appropriate method of contraception [abstinence, oral contraceptives, IUD, condoms with spermicidal foam, surgical sterilization depots and injectable contraceptives, or diaphragms with spermicidal jelly or cream] 30 days prior to the Week 12 visit.

Exclusion Criteria:

-Chronic diarrhea, inflammatory bowel disease, irritable bowel syndrome, or other gastrointestinal disorder, gastrointestinal surgery (except appendectomy, polypectomy, or herniorraphy), or severe chronic illness such as major organ failure, diabetes, HIV/AIDS. -Female who is pregnant or lactating; or a female subject with a positive urine pregnancy test determined at the Week 12 visit. -History of hypersensitivity to Ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any compound of the product. -History of tendinitis or tendon rupture. -History of seizures other than febrile seizure as a young child. -Treatment with antibiotics within one month before the initial specimen collection. -History of clinically significant acute or chronic illness or other condition requiring chronic medication therapy (including systemic but not intranasal steroids), except for birth control pills, inhalers, anti-anxiety or anti-depression medications. -History of cardiac rhythm abnormalities or QT prolongation or a family history of cardiac rhythm abnormalities or sudden unexplained death. -History of current or past use of theophylline for asthma or tizanidine, due to known interaction with Ciprofloxacin. -History of spasticity (due to the potential for requiring tizanidine treatment), asthma, chronic bronchitis, emphysema, and other lung diseases (due to potential for requiring theophylline [or dimethylxanthine] treatment). -Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.

Sites / Locations

  • University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cipro

Arm Description

At Week 12, subjects will receive a 3-day course of oral Ciprofloxacin 500 mg every 12h.

Outcomes

Primary Outcome Measures

Analysis of GI microbial community composition using the Affymetrix PhyloChip Platform.
Isolation of Genomic DNA from stool samples.
Surveys of GI microbiome diversity using 16S rDNA analysis at the Institute of Genome Sciences.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2009
Last Updated
July 22, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00832286
Brief Title
Longitudinal Study of the Human Intestinal Microbiome
Official Title
Longitudinal Study of the Human Intestinal Microbiome Before and After Antibiotic Administration
Study Type
Interventional

2. Study Status

Record Verification Date
February 8, 2011
Overall Recruitment Status
Completed
Study Start Date
July 23, 2009 (Actual)
Primary Completion Date
September 24, 2010 (Actual)
Study Completion Date
January 11, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this study is to identify the human intestinal microbiota (microbes that live inside and on human bodies) in healthy adults over a 6-month period and to study the effect of an antibiotic on the intestinal microbiota. Participants will include up to 60 healthy adult subjects, ages 18-45 years, from the Baltimore and University of Maryland communities. Study procedures will include providing multiple stool samples throughout the study. Participants will take a licensed antibiotic, Ciprofloxacin, for 3 days. Participants may be involved in study related procedures for up to 7 months.
Detailed Description
The purpose of this study is to describe the intestinal microbiomes of a cohort of healthy adult subjects over a 6-month period of time. Many questions about the human microbiota exist. Previous studies have shown that the differences among individuals are greater than the differences among different sampling sites in a single individual. Up to 60 healthy adult subjects, ages 18-45 years, from the Baltimore and University of Maryland Baltimore communities will be recruited and screened to document their health status. A brief medical history, including recent travel and antibiotic use, will be recorded. Subjects will provide a stool specimen for genomic analysis of the intestinal microbiome over a 6-month period at the following intervals: Day 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 13, Week 14, Week 15, Week 16, Week 20, and Week 24. At Week 12, subjects will receive a 3-day course of oral Ciprofloxacin 500 mg every12 hours. Weekly stool specimens will be obtained beginning with the first day of antibiotic use and for 4 Weeks thereafter. Then monthly specimens of stool and other sites will be resumed at Week 16. The primary objective is to define the human intestinal microbiome in healthy adults in a longitudinal fashion. The secondary objective is to define the re-colonization of the intestine after treatment with a broad-spectrum antibiotic using comprehensive genomic techniques. Each subject will participate in the study for up to 7 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysbacteriosis
Keywords
genomic techniques, intestinal microbiome

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cipro
Arm Type
Experimental
Arm Description
At Week 12, subjects will receive a 3-day course of oral Ciprofloxacin 500 mg every 12h.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Licensed medication, dose: 500 mg every 12 hours for 3 days.
Primary Outcome Measure Information:
Title
Analysis of GI microbial community composition using the Affymetrix PhyloChip Platform.
Time Frame
Analysis.
Title
Isolation of Genomic DNA from stool samples.
Time Frame
Weekly stool samples will be obtained for over a 6-month period at the following intervals: Day 0, Weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16, 20, and 24.
Title
Surveys of GI microbiome diversity using 16S rDNA analysis at the Institute of Genome Sciences.
Time Frame
Analysis.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -Male or female, ages 18 to 45 years, inclusive. -Healthy as determined by screening medical history, medication history, and absence of acute illness such as gastrointestinal or respiratory infection. -Capable of understanding, consenting and complying with the entire study protocol. -Provide voluntary written Informed Consent. -Females of childbearing potential are required to utilize an appropriate method of contraception [abstinence, oral contraceptives, IUD, condoms with spermicidal foam, surgical sterilization depots and injectable contraceptives, or diaphragms with spermicidal jelly or cream] 30 days prior to the Week 12 visit. Exclusion Criteria: -Chronic diarrhea, inflammatory bowel disease, irritable bowel syndrome, or other gastrointestinal disorder, gastrointestinal surgery (except appendectomy, polypectomy, or herniorraphy), or severe chronic illness such as major organ failure, diabetes, HIV/AIDS. -Female who is pregnant or lactating; or a female subject with a positive urine pregnancy test determined at the Week 12 visit. -History of hypersensitivity to Ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any compound of the product. -History of tendinitis or tendon rupture. -History of seizures other than febrile seizure as a young child. -Treatment with antibiotics within one month before the initial specimen collection. -History of clinically significant acute or chronic illness or other condition requiring chronic medication therapy (including systemic but not intranasal steroids), except for birth control pills, inhalers, anti-anxiety or anti-depression medications. -History of cardiac rhythm abnormalities or QT prolongation or a family history of cardiac rhythm abnormalities or sudden unexplained death. -History of current or past use of theophylline for asthma or tizanidine, due to known interaction with Ciprofloxacin. -History of spasticity (due to the potential for requiring tizanidine treatment), asthma, chronic bronchitis, emphysema, and other lung diseases (due to potential for requiring theophylline [or dimethylxanthine] treatment). -Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
Facility Information:
Facility Name
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1509
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Longitudinal Study of the Human Intestinal Microbiome

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