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IBS - Irritable Bowel SyndromeNCT04348760

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

A study testing Rotation Diet in people with IBS - Irritable Bowel Syndrome and Inflammation, run by GEK Srl at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
IBS - Irritable Bowel Syndrome, Inflammation
What is being tested?
Rotation Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
1 May 2019to 30 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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,...)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • GEK srl

    Milan, 20149

Other trials in Italy

About this study

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

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.

Read the 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

Being tested
Rotation Diet
Medical subject headings
Irritable Bowel Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotation DietBehavioural

    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.

Study groups in NCT04348760
Study groupRoleWhat they receive
InterventionExperimentalSubjects 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
Receives: Behavioral: Rotation Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BAFF levels

    reduction of BAFF levels from baseline

    Measured: 6 weeks

  2. PAF levels

    reduction of PAF levels from baseline

    Measured: 6 weeks

Secondary outcomes (2)

  1. IBS symptom severity

    IBS symptom severity score reduction from baseline

    Measured: 6 weeks

  2. BMI

    BMI reduction from baseline

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2020
  2. Study start1 May 2019
  3. Primary completion30 Jul 2019
  4. Study completion30 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04348760
Sponsor's protocol ID
2019_01_IBS
Status last verified
Apr 2020
First submitted
14 Apr 2020
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participants data that underline the results reported in article, after deidentification (text, tables)

Publications

  • 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.

    PubMed 30288077

  • 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.

    PubMed 20353497

  • 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.

    PubMed 23170971

  • 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.

    PubMed 33292297

Questions about this trial

What is this clinical trial studying?

A study testing Rotation Diet in people with IBS - Irritable Bowel Syndrome and Inflammation, run by GEK Srl at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BAFF levels (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04348760, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.

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