Obesity, MorbidPhase 1NCT05367479
Antibiotics, Gastric Bypass, and the Microbiome
A Phase 1 study testing Antibiotic in people with Obesity, Morbid and Hypertension, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study randomizes patients to two commonly used peri-procedural antibiotics after gastric bypass with the pre and post-operative collection of stool samples, to identify significant differences in relative abundances of gut microbiota phyla, genera and species between the two antibiotic groups used. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Morbid, Hypertension, Bariatric Surgery Candidate
- What is being tested?
- Antibiotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 9 Jan 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patients who are approved for a primary RYGB at MCW's bariatric surgery program as treatment for morbid obesity and obesity-associated co-morbidities. Patients will be eligible who are: 1.) female or male 2.) 18-70 years of age, 3.) hypertensive
Exclusion Criteria: Patients are ineligible if they: 1.) have a diagnosis of cirrhosis, 2.) are taking antibiotics, probiotics, or immune modulating medications for one month prior to or after surgery, 3.) have a history of bowel resections, inflammatory bowel disease and/or celiac disease, 4.) have a life-threatening reaction to penicillin/cephalosporins or clindamycin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peri-operative Antibiotic Class on Microbiome Changes After Roux-en-Y Gastric Bypass
This study randomizes patients to two commonly used peri-procedural antibiotics after gastric bypass with the pre and post-operative collection of stool samples, to identify significant differences in relative abundances of gut microbiota phyla, genera and species between the two antibiotic groups used. Gastric bypass may beneficially affect hypertension by altering the post-operative microbiome and specific antibiotics can further enhance the resolution rate by improving microbial diversity and richness.
Read the detailed description
Eligible patients will be reviewed to meet inclusion criteria. Patients will be approached for enrollment at their pre-operative clinic appointment. If patients agree, consent will be signed.
Demographics will be collected on all patients including past medical, surgical and obesity history. Blood pressure will be recorded in the office, hypertensive medication record reviewed, post-operative follow-up and stool samples will be collected at 5 visits (V1-V5): 2 weeks pre-op, day of surgery, 2 weeks post-op, and 3 months post-op. Patients will be randomized at the time of surgery to receive intravenous cefazolin or clindamycin (weight-based dosing) as a pre-operative antibiotic within 60 minutes of incision time. Both antibiotics are routinely used as a single intravenous pre-operative dose for surgical site infection prophylaxis during Roux-en-Y gastric bypass and does not alter the standard of care. In routine care, clindamycin is given when there is a cefazolin allergy. Vancomycin is given if there is an allergy to both. We have a protocol that all bariatric surgeons follow rather than preference. There should be equipoise regarding the risk of a skin, superficial or deep surgical site infection between the two choices.
Hypertension will be considered resolved when the blood pressure is <140/90 without medication. Data points for collection were chosen to identify both short and long-term changes in the microbiome as well as assess for changes in the microbiome related to dietary modifications required with surgery.
Stool samples will be collected from participants in this study. Stool samples will be collected at the convenience of the participant at time points designated in the study design. The participant will be given a stool sample kit(s) to take home during the time of consent. The stool sample will be received by the research laboratory at a follow-up visit, or returned via FedEx with materials supplied in the stool collection kit. Following receipt in the laboratory, the stool samples will be stored in Dr. Kindel's lab (4th floor CRI) at -80 degrees where they will later undergo bacterial genomic DNA and RNA isolation using standardized techniques and later analysis for 16S and metagenomic sequencing analysis.
- Conditions
- Obesity, Morbid, Hypertension, Bariatric Surgery Candidate
- Being tested
- Antibiotic
- Keywords
- gut microbiome
- Medical subject headings
- Obesity, Morbid, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Peri-operative, intravenous antibiotic for surgical site infection
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Active comparator | standard of care as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based. Receives: Drug: Antibiotic |
| Clindamycin | Active comparator | also standard of care alternative as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based. Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
operational taxonomic units
a distinct bacterial community
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start18 Jul 2018
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammy Kindel, MD, PhD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367479
- Sponsor's protocol ID
- PRO00030985
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peri-operative Antibiotic Class on Microbiome Changes After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT05367479
- Acronym / sponsor ID
- PRO00030985
- Conditions
- Obesity, Morbid, Hypertension, Bariatric Surgery Candidate
- Keywords
- gut microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 10 May 2022 (actual)
- 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.
This study randomizes patients to two commonly used peri-procedural antibiotics after gastric bypass with the pre and post-operative collection of stool samples, to identify significant differences in relative abundances of gut microbiota phyla, genera and species between the two antibiotic groups used. Gastric bypass may beneficially affect hypertension by altering the post-operative microbiome and specific antibiotics can further enhance the resolution rate by improving microbial diversity and richness.
Detailed description
Eligible patients will be reviewed to meet inclusion criteria. Patients will be approached for enrollment at their pre-operative clinic appointment. If patients agree, consent will be signed.
Demographics will be collected on all patients including past medical, surgical and obesity history. Blood pressure will be recorded in the office, hypertensive medication record reviewed, post-operative follow-up and stool samples will be collected at 5 visits (V1-V5): 2 weeks pre-op, day of surgery, 2 weeks post-op, and 3 months post-op. Patients will be randomized at the time of surgery to receive intravenous cefazolin or clindamycin (weight-based dosing) as a pre-operative antibiotic within 60 minutes of incision time. Both antibiotics are routinely used as a single intravenous pre-operative dose for surgical site infection prophylaxis during Roux-en-Y gastric bypass and does not alter the standard of care. In routine care, clindamycin is given when there is a cefazolin allergy. Vancomycin is given if there is an allergy to both. We have a protocol that all bariatric surgeons follow rather than preference. There should be equipoise regarding the risk of a skin, superficial or deep surgical site infection between the two choices.
Hypertension will be considered resolved when the blood pressure is <140/90 without medication. Data points for collection were chosen to identify both short and long-term changes in the microbiome as well as assess for changes in the microbiome related to dietary modifications required with surgery.
Stool samples will be collected from participants in this study. Stool samples will be collected at the convenience of the participant at time points designated in the study design. The participant will be given a stool sample kit(s) to take home during the time of consent. The stool sample will be received by the research laboratory at a follow-up visit, or returned via FedEx with materials supplied in the stool collection kit. Following receipt in the laboratory, the stool samples will be stored in Dr. Kindel's lab (4th floor CRI) at -80 degrees where they will later undergo bacterial genomic DNA and RNA isolation using standardized techniques and later analysis for 16S and metagenomic sequencing analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Active comparator | Drug: Antibioticstandard of care as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based. |
| Clindamycin | Active comparator | Drug: Antibioticalso standard of care alternative as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AntibioticPeri-operative, intravenous antibiotic for surgical site infection | Drug | Cefazolin, Clindamycin |
Primary outcome
operational taxonomic units
Time frame: 3 months postoperatively
a distinct bacterial community
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 10 May 2022.
- Individual participant dataSharing planned: No
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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 Antibiotic in people with Obesity, Morbid and Hypertension, run by Medical College of Wisconsin 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?
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 10 May 2022. 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?
operational taxonomic units (time frame: 3 months postoperatively). 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 10 May 2022.