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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
Sponsor:
Collaborator:
Hippocrates Research
Information provided by (Responsible Party):
GEK Srl

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.

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Inflammation Behavioral: Rotation Diet Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Intervention
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.




Primary Outcome Measures :
  1. BAFF levels [ Time Frame: 6 weeks ]
    reduction of BAFF levels from baseline

  2. PAF levels [ Time Frame: 6 weeks ]
    reduction of PAF levels from baseline


Secondary Outcome Measures :
  1. IBS symptom severity [ Time Frame: 6 weeks ]
    IBS symptom severity score reduction from baseline

  2. BMI [ Time Frame: 6 weeks ]
    BMI reduction from baseline



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,...)

Information from the National Library of Medicine

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


Locations
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Italy
GEK srl
Milano, Italy, 20149
Sponsors and Collaborators
GEK Srl
Hippocrates Research
Investigators
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Principal Investigator: Emiliana Tognon, PhD GEK Srl
Principal Investigator: Mattia Cappelletti, MD SMA srl
Study Director: Attilio F Speciani, MD GEK Srl
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GEK Srl
ClinicalTrials.gov Identifier: NCT04348760    
Other Study ID Numbers: 2019_01_IBS
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participants data that underline the results reported in article, after deidentification (text, tables)
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: immediately following and for 36 months after publication
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Inflammation
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases