Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

Human Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731976
• Other study ID #: M12.113965
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• healthy participants aged >=16

Exclusion Criteria:

• Known gastrointestinal disorder
• Known food intolerance

Related Conditions & MeSH terms

• Human Microbiome

Intervention

Other:
• Dietary intervention

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut microbiota composition upon gluten-free diet intervention		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal calprotectin		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: plasma cytokines: IL-1beta		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal human beta defensin 2		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal chromogranin A		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: plasma citrulline		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: plasma cytokines: IL-6		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: plasma cytokines: IL-8		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: plasma cytokines: IL-10		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: plasma cytokines: IL-12		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary	Changes in gut associated biomarker levels: plasma cytokines: TNFalpha		baseline, 4 weeks gluten-free diet and 4 weeks habitual diet