Small Intestine BacteriaMicrobiotaNCT03266536
Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
A study testing Western diet in people with Small Intestine Bacteria, run by Mayo Clinic at 1 site in United States.
Trial summary
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet? Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Intestine Bacteria
- What is being tested?
- Western diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2017to 19 May 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between (and including) 18-65 years old.
- On a baseline healthy diet characterized by:
- High fiber of ≥ 14 g/1000 calories/day
- < 10% of daily calories from added sugar
- At least 5 servings of fruit and vegetables per day
- < or = 13% of daily calories from saturated fat
Who cannot join
- Patients who do not meet the above diet requirements.
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
- Presence of abdominal symptoms based on baseline questionnaire.
- Commercial oral antibiotic or probiotic use within the past 4 weeks.
- Pregnancy or plans to become pregnant within the study time frame
- Vulnerable adults
- Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?
Read the detailed description
The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.
- Conditions
- Small Intestine Bacteria
- Being tested
- Western diet
- Keywords
- Gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western dietBehavioural
Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.
| Study group | Role | What they receive |
|---|---|---|
| No western diet | No intervention | Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete. |
| Western diet | Experimental | Participants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies). Receives: Behavioral: Western diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional changes in gut microbiota present in stool.
DNA extraction from stool samples will be done using standard assays.
Measured: Baseline, approximately three weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start9 Jan 2017
- Primary completion16 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestine BacteriaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Colorado State University, University of Minnesota, Imperial College London
- Responsible party
- Principal investigator, Purna C. Kashyap, MBBS, Mayo Clinic
- Investigators
- Purna C Kashyap, M.B.B.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266536
- Sponsor's protocol ID
- 16-006388
- Acronym
- Microbiota
- Status last verified
- May 2022
- First submitted
- 26 Oct 2016
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Principal investigator will protect the safety of subjects, the validity of data and the integrity of the research by assigning a study identification number to the subject. All information will be kept in a locked file cabinet and all data will be in a password protected computer database. All specimens will be stored in the principal investigator's freezer.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
- ClinicalTrials.gov ID
- NCT03266536
- Acronym / sponsor ID
- Microbiota / 16-006388
- Conditions
- Small Intestine Bacteria
- Keywords
- Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Colorado State University, University of Minnesota, Imperial College London
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 30 Aug 2017 (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.
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?
Detailed description
The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No western diet | No intervention | –Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete. |
| Western diet | Experimental | Behavioral: Western dietParticipants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between (and including) 18-65 years old.
- On a baseline healthy diet characterized by:
Key exclusion criteria (7 listed)
- Patients who do not meet the above diet requirements.
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
- Presence of abdominal symptoms based on baseline questionnaire.
- Commercial oral antibiotic or probiotic use within the past 4 weeks.
- Pregnancy or plans to become pregnant within the study time frame
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 |
|---|---|---|
| Western dietWestern diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars. | Behavioural | Western diet |
Primary outcome
Transcriptional changes in gut microbiota present in stool.
Time frame: Baseline, approximately three weeks.
DNA extraction from stool samples will be done using standard assays.
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 4 May 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Principal investigator will protect the safety of subjects, the validity of data and the integrity of the research by assigning a study identification number to the subject. All information will be kept in a locked file cabinet and all data will be in a password protected computer database. All specimens will be stored in the principal investigator's freezer.
Related trials for Small Intestine Bacteria
Enrolling by invitationObservational study
Small Intestinal Bacterial Overgrowth: A Prospective Registry
Functional Dyspepsia, Small Intestinal Bacterial Overgrowth
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.
Purna C Kashyap, M.B.B.S. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western diet in people with Small Intestine Bacteria, run by Mayo Clinic 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 6 inclusion and 7 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 4 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.
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?
Transcriptional changes in gut microbiota present in stool. (time frame: Baseline, approximately three weeks.). 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 4 May 2022.