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NCT Number: NCT04348760

Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS

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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Inflammation Intestinal Diseases Irritable Bowel Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GEK srl

Milan, 20149, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,...)

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GEK Srl

Industry

Collaborators

  • Hippocrates Research

Registry information

Official study title

Study of Two Inflammatory Cytokines, BAFF and PAF, and Their Clinical Relevance Before and After a Personalized Nutritional Intervention in IBS Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2020
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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