DysbacteriosisPhase 1NCT00832286
Longitudinal Study of the Human Intestinal Microbiome
A Phase 1 study testing Ciprofloxacin in people with Dysbacteriosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysbacteriosis
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2009to 11 Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
About this study
Official title: Longitudinal Study of the Human Intestinal Microbiome Before and After Antibiotic Administration
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.
Read the 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.
- Conditions
- Dysbacteriosis
- Being tested
- Ciprofloxacin
- Keywords
- genomic techniques, intestinal microbiome
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Licensed medication, dose: 500 mg every 12 hours for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Cipro | Experimental | At Week 12, subjects will receive a 3-day course of oral Ciprofloxacin 500 mg every 12h. Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of GI microbial community composition using the Affymetrix PhyloChip Platform.
Measured: Analysis.
Isolation of Genomic DNA from stool samples.
Measured: 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.
Surveys of GI microbiome diversity using 16S rDNA analysis at the Institute of Genome Sciences.
Measured: Analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study start23 Jul 2009
- Primary completion24 Sep 2010
- Study completion11 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbacteriosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832286
- Sponsor's protocol ID
- 07-0053
- Status last verified
- 8 Feb 2011
- First submitted
- 29 Jan 2009
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of the Human Intestinal Microbiome Before and After Antibiotic Administration
- ClinicalTrials.gov ID
- NCT00832286
- Acronym / sponsor ID
- 07-0053
- Conditions
- Dysbacteriosis
- Keywords
- genomic techniques, intestinal microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Jul 2009 (actual)
- Primary completion
- 24 Sep 2010 (actual)
- Study completion
- 11 Jan 2011 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cipro | Experimental | Drug: CiprofloxacinAt Week 12, subjects will receive a 3-day course of oral Ciprofloxacin 500 mg every 12h. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinLicensed medication, dose: 500 mg every 12 hours for 3 days. | Drug | Cipro |
Primary outcome
Analysis of GI microbial community composition using the Affymetrix PhyloChip Platform.
Time frame: Analysis.
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.
Surveys of GI microbiome diversity using 16S rDNA analysis at the Institute of Genome Sciences.
Time frame: Analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ciprofloxacin in people with Dysbacteriosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of GI microbial community composition using the Affymetrix PhyloChip Platform. (time frame: Analysis.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021; AzTrials last refreshed its copy on 1 Nov 2026.