Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS
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|ClinicalTrials.gov Identifier: NCT04348760|
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|IBS - Irritable Bowel Syndrome Inflammation||Behavioral: Rotation Diet||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Two Inflammatory Cytokines, BAFF and PAF, and Their Clinical Relevance Before and After a Personalized Nutritional Intervention in IBS Subjects|
|Actual Study Start Date :||May 1, 2019|
|Actual Primary Completion Date :||July 30, 2019|
|Actual Study Completion Date :||July 30, 2019|
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
Behavioral: Rotation 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.
- BAFF levels [ Time Frame: 6 weeks ]reduction of BAFF levels from baseline
- PAF levels [ Time Frame: 6 weeks ]reduction of PAF levels from baseline
- IBS symptom severity [ Time Frame: 6 weeks ]IBS symptom severity score reduction from baseline
- BMI [ Time Frame: 6 weeks ]BMI reduction from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348760
|Milano, Italy, 20149|
|Principal Investigator:||Emiliana Tognon, PhD||GEK Srl|
|Principal Investigator:||Mattia Cappelletti, MD||SMA srl|
|Study Director:||Attilio F Speciani, MD||GEK Srl|