Human MicrobiomeNCT02731976
Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge
A study testing Dietary intervention in people with Human Microbiome, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to May 2014
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy participants aged >=16
Who cannot join
- Known gastrointestinal disorder
- Known food intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome
Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.
- Conditions
- Human Microbiome
- Being tested
- Dietary intervention
- Keywords
- Gluten-Free diet, Healthy individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
| Study group | Role | What they receive |
|---|---|---|
| GFD | Experimental | After instruction of a dietician, participants adhered to a gluten-free diet for 4 weeks. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota composition upon gluten-free diet intervention
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary outcomes (15)
Changes in gut associated biomarker levels: fecal calprotectin
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-1beta
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal human beta defensin 2
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal chromogranin A
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma citrulline
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-6
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-8
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-10
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-12
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: TNFalpha
Measured: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731976
- Sponsor's protocol ID
- M12.113965
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2016
- Last updated
- 18 Apr 2024
- Results posted
- No
Publications
Baranska A, Tigchelaar E, Smolinska A, Dallinga JW, Moonen EJ, Dekens JA, Wijmenga C, Zhernakova A, van Schooten FJ. Profile of volatile organic compounds in exhaled breath changes as a result of gluten-free diet. J Breath Res. 2013 Sep;7(3):037104. doi: 10.1088/1752-7155/7/3/037104. Epub 2013 Jun 18.
PubMed 23774130
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome
- ClinicalTrials.gov ID
- NCT02731976
- Acronym / sponsor ID
- M12.113965
- Conditions
- Human Microbiome
- Keywords
- Gluten-Free diet, Healthy individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Apr 2016 (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.
Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GFD | Experimental | Other: Dietary interventionAfter instruction of a dietician, participants adhered to a gluten-free diet for 4 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy participants aged >=16
Key exclusion criteria (2 listed)
- Known gastrointestinal disorder
- Known food intolerance
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 |
|---|---|---|
| Dietary intervention | Other | GFD |
Primary outcome
Changes in gut microbiota composition upon gluten-free diet intervention
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
15 secondary outcomes
Changes in gut associated biomarker levels: fecal calprotectin
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-1beta
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal human beta defensin 2
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal chromogranin A
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma citrulline
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-6
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-8
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-10
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-12
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: TNFalpha
Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
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 18 Apr 2024.
- Results publication: PubMed 23774130Baranska A, Tigchelaar E, Smolinska A, Dallinga JW, Moonen EJ, Dekens JA, Wijmenga C, Zhernakova A, van Schooten FJ. Profile of volatile organic compounds in exhaled breath changes as a result of gluten-free diet. J Breath Res. 2013 Sep;7(3):037104. doi: 10.1088/1752-7155/7/3/037104. Epub 2013 Jun 18.
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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 study testing Dietary intervention in people with Human Microbiome, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 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 18 Apr 2024. 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 Netherlands. 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?
Changes in gut microbiota composition upon gluten-free diet intervention (time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02731976, which also lists 1 linked publication.
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 18 Apr 2024.