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| Name | Class |
|---|---|
| Hippocrates Research | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotation Diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BAFF levels | reduction of BAFF levels from baseline | 6 weeks |
| PAF levels | reduction of PAF levels from baseline | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IBS symptom severity | IBS symptom severity score reduction from baseline | 6 weeks |
| BMI | BMI reduction from baseline | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emiliana Tognon, PhD | GEK Srl | Principal Investigator |
| Mattia Cappelletti, MD | SMA srl | Principal Investigator |
| Attilio F Speciani, MD | GEK Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GEK srl | Milan | 20149 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30288077 | Background | Ng QX, Soh AYS, Loke W, Lim DY, Yeo WS. The role of inflammation in irritable bowel syndrome (IBS). J Inflamm Res. 2018 Sep 21;11:345-349. doi: 10.2147/JIR.S174982. eCollection 2018. | |
| 20353497 | Background | Lied GA, Lillestol K, Valeur J, Berstad A. Intestinal B cell-activating factor: an indicator of non-IgE-mediated hypersensitivity reactions to food? Aliment Pharmacol Ther. 2010 Jul;32(1):66-73. doi: 10.1111/j.1365-2036.2010.04314.x. Epub 2010 Mar 26. |
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Individual participants data that underline the results reported in article, after deidentification (text, tables)
immediately following and for 36 months after publication
Proposals should be directed to the PI/Sponsor. To gain access, data requestors will need to sign a data access agreement
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 23170971 | Background | Ligaarden SC, Lydersen S, Farup PG. IgG and IgG4 antibodies in subjects with irritable bowel syndrome: a case control study in the general population. BMC Gastroenterol. 2012 Nov 21;12:166. doi: 10.1186/1471-230X-12-166. |
| 33292297 | Derived | Cappelletti M, Tognon E, Vona L, Basello K, Costanzi A, Speciani MC, Speciani AF. Food-specific serum IgG and symptom reduction with a personalized, unrestricted-calorie diet of six weeks in Irritable Bowel Syndrome (IBS). Nutr Metab (Lond). 2020 Dec 1;17(1):101. doi: 10.1186/s12986-020-00528-x. |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |