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Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02731976
Enrollment
21
Registered
2016-04-08
Start date
2011-11-30
Completion date
2014-05-31
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Microbiome

Keywords

Gluten-Free diet, Healthy individuals

Brief 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. 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.

Interventions

OTHERDietary intervention

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy participants aged \>=16

Exclusion criteria

* Known gastrointestinal disorder * Known food intolerance

Design outcomes

Primary

MeasureTime frame
Changes in gut microbiota composition upon gluten-free diet interventionbaseline, 4 weeks gluten-free diet and 4 weeks habitual diet

Secondary

MeasureTime frame
Changes in gut associated biomarker levels: plasma cytokines: IL-6baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal calprotectinbaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-1betabaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal human beta defensin 2baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal chromogranin Abaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: propionatebaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma citrullinebaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: caproatebaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: butyratebaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: valeratebaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-8baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-10baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-12baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: TNFalphabaseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: acetatebaseline, 4 weeks gluten-free diet and 4 weeks habitual diet

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026