Status:
COMPLETED
Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS
Lead Sponsor:
GEK Srl
Collaborating Sponsors:
Hippocrates Research
Conditions:
IBS - Irritable Bowel Syndrome
Inflammation
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life. Despite the prevalence of IBS, its etiology and pathophysiology are ...
Detailed Description
The investigators enrolled 30 subjects with diagnosis of IBS, according to Rome-IV criteria, whose inflammatory markers were measured at baseline and after 6 weeks of dietary intervention. The subject...
Eligibility Criteria
Inclusion
- IBS (according to ROME IV criteria)
- blood analysis within 1yr with CBC, TSHr, ESR, CRP, urine, glucose
- attitude to change dietary habits
- willing to follow study protocol
Exclusion
- low BMI (\<18.5 kg/m2)
- pregnancy
- restrictive dietary habits (e.g. veganism)
- positive FOBT
- faecal calprotectin \>200 mcg/g
- known or recurrent bowel infections
- known or recurrent UTI (\>3/yr)
- former diverticulitis
- alcohol abuse
- major concurrent disease (e.g. IBD, coeliac disease, eating disorder,...)
- pharmacological treatment with drugs that alter intestinal motility (e.g. PPI, metformin,...)
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04348760
Start Date
May 1 2019
End Date
July 30 2019
Last Update
April 17 2020
Active Locations (1)
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1
GEK srl
Milan, Italy, 20149