The FIDGIT Study. Exploring the relationship between Fibromyalgia, Digestive Markers and the Gastrointestinal Tract in adult women.

Not Applicable

Completed

• Conditions: Fibromyalgia; Functional gastrointestinal disorders; Musculoskeletal - Other muscular and skeletal disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Neurological - Other neurological disorders

• Registration Number: ACTRN12620001337965
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-11
• Study Completion: 2023-01-09
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

Adult women meeting ACR2016 criteria for fibromyalgia and age & gender-matched controls.
Must be willing to provide biological samples that will be sent overseas for analysis with microbiome data potentially becoming part of a larger biobank.

Exclusion Criteria

Diabetes or any other condition precluding fasting for 15 hours, pregnancy, any major comorbid illness (e.g. malignancy, active inflammatory or metabolic
disease), taking chronic NSAID analgaesics (and unable to cease for 2 days prior to sample collection),or immune-modifying medication. Antibiotic use within previous 4 weeks (deferral is an option). Unable to provide informed consent or complete questionnaires in English. Participants unwilling to submit biological samples in accordance with the study protocol.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obtain measures of gastrointestinal bacteria from oral and faecal samples[Single oral and faecal samples will be obtained at baseline.];Measure breath hydrogen and methane gas (and hydrogen sulphide if equipment becomes available) on three occasions: 1. Oral glucose challenge: 50g glucose [or 1g/kg if less than 50kg body weight], Breath gases measured every 15 minutes for 120 mins 2. Oral lactulose challenge: 10g lactulose, Breath gases measured every 15 mins for 3 hours 3. Oral fructose challenge: 25g fructose in 300ml water. Breath gases measured every 15 minutes for 180 mins.[At baseline, each test conducted on a separate occasions, at least 2 days apart.];Measure symptoms of fibromyalgia, as assessed by American College of Rheumatology (ACR) 2106 criteria.[At baseline. ]