Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

Study Overview
=================
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.

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

Conditions
-----------------
Human Microbiome

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy participants aged >=16 Exclusion Criteria: Known gastrointestinal disorder Known food intolerance

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GFD<br>After instruction of a dietician, participants adhered to a gluten-free diet for 4 weeks. | Other: Dietary intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut microbiota composition upon gluten-free diet intervention |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut associated biomarker levels: fecal calprotectin |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: plasma cytokines: IL-1beta |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: fecal human beta defensin 2 |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: fecal chromogranin A |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: plasma citrulline |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: plasma cytokines: IL-6 |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: plasma cytokines: IL-8 |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: plasma cytokines: IL-10 |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: plasma cytokines: IL-12 |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 
| Changes in gut associated biomarker levels: plasma cytokines: TNFalpha |  | baseline, 4 weeks gluten-free diet and 4 weeks habitual diet | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gluten-Free diet, Healthy individuals