IBS - Irritable Bowel Syndrome, Inflammation
Conditions
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 still to be fully understood, but immune response is known to be involved. In this study, the investigators researched the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS), following a personalized an unrestricted-calorie diet.
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 subjects were monitored in a general practice outpatient setting (GP) and nutritional advice was offered remotely via two telephone sessions with a nutritionist. The researchers investigated the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS). Data monitoring was ensured by an external monitor (Hippocrates Research, Genova, Italy). All data entry was in accordance with GCP protocol, and AE were classified using CTCAE 4.0
Interventions
BEHAVIORALRotation Diet
Based on the food-specific IgG measurement and relative distribution, a personalized food profile was created for each subject identifying 1 to 3 relevant food groups/nutritional clusters. Subjects were then instructed to avoid the foods highlighted in their personal food profile in certain days of the week, and to assume them in 7 of the 21 meals of the week. No calorie restriction was imposed in the diet.
Sponsors
Hippocrates Research
GEK Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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,...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BAFF levels | 6 weeks | reduction of BAFF levels from baseline |
| PAF levels | 6 weeks | reduction of PAF levels from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IBS symptom severity | 6 weeks | IBS symptom severity score reduction from baseline |
| BMI | 6 weeks | BMI reduction from baseline |
Countries
Italy
Outcome results
None listed