Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT02731976
• Date of registration: 04/04/2016
• Prospective Registration: No
• Primary sponsor: University Medical Center Groningen
• Public title: Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge
• Scientific title: The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome
• Date of first enrolment: November 2011
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02731976
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

Inclusion Criteria:

- healthy participants aged >=16

Exclusion Criteria:

- Known gastrointestinal disorder

- Known food intolerance



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Human Microbiome

Intervention(s)

Other: Dietary intervention

Primary Outcome(s)

Changes in gut microbiota composition upon gluten-free diet intervention [Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]

Secondary Outcome(s)

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 short chain fatty acids: valerate [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 calprotectin [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: 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: 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: plasma cytokines: IL-6 [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: 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: plasma cytokines: TNFalpha [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-1beta [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: plasma cytokines: IL-8 [Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]

Secondary ID(s)

M12.113965

Source(s) of Monetary Support

Please refer to primary and secondary sponsors