Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome (IBS-CDED)

12. juli 2026 oppdatert av: Ariel University

Open-Label, Randomized Controlled Study to Assess the Efficacy of a Modified Crohn's Disease Exclusion Diet (CDED) Versus Low FODMAP Diet for Managing Non-Constipation Irritable Bowel Syndrome

Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population.

Objectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability.

Methods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150.

Following a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries [Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point.

Stool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes.

Significance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction characterized by chronic gastrointestinal symptoms in the absence of structural disease. Increasing evidence suggests that, particularly in non-constipated IBS (IBS-D and IBS-M), impaired intestinal barrier function, gut microbiota dysbiosis, mucosal immune activation, and low-grade inflammation contribute to symptom generation. These findings have shifted the focus of research toward dietary strategies that target underlying biological mechanisms rather than symptom reduction alone.

The low FODMAP diet is currently the most extensively studied dietary intervention for IBS and is recommended by international guidelines. However, despite its effectiveness in reducing gastrointestinal symptoms, concerns remain regarding its potential adverse effects on gut microbial diversity and the lack of evidence for improvement in intestinal inflammation or barrier integrity.

The Crohn's Disease Exclusion Diet (CDED) was originally developed for patients with Crohn's disease and has demonstrated favorable effects on intestinal inflammation, epithelial barrier function, and gut microbiota composition. Because several of these biological pathways are also implicated in IBS pathophysiology, an adapted version of the CDED may provide clinical benefits while simultaneously targeting disease mechanisms that are not addressed by current dietary approaches.

This study will evaluate, for the first time, an IBS-oriented adaptation of the CDED that excludes the enteral formula component used in Crohn's disease. In addition to evaluating clinical efficacy, the study will investigate potential biological mechanisms through serial assessment of fecal inflammatory markers, intestinal permeability markers, and gut microbiota composition. By integrating clinical, psychological, and biological outcomes, the study aims to determine whether this dietary intervention represents a mechanism-based alternative to the current dietary standard of care for patients with non-constipated IBS.

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria.
  • Moderate-to-severe symptoms (IBS-SSS score ≥175).
  • Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics

Exclusion Criteria:

  • Coexisting GI diseases [e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease [positive transglutaminase (TTG) serology].
  • Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease [abnormal Thyroid-Stimulating Hormone (TSH)], and bariatric surgery.
  • Recent intestinal resection.
  • Pregnancy or breastfeeding.
  • Known food allergies.
  • Current active eating disorder
  • Participants already following a restrictive diet, including diets that overlap with the interventions in this study, will be excluded to prevent confounding effects on gut microbiota composition and gastrointestinal symptoms, and to ensure consistent baseline conditions. However, individuals who have discontinued such diets at least two to four weeks prior to enrollment may be eligible, allowing for a sufficient dietary washout period to minimize residual effects on the gut microbiota.
  • Currently under obesity management medication treatment.
  • Vegans
  • Use of antibiotics within the 4 weeks prior to enrollment or during the study period.
  • Abnormal hemoglobin levels (for women<11.5 gr/dl, for men<13 gr/dl)29
  • Baseline CRP≥5

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Modified Crohn's Disease Exclusion Diet (CDED)
Participants randomized to this arm will follow a modified Crohn's Disease Exclusion Diet (CDED) adapted for patients with irritable bowel syndrome. The intervention excludes the enteral formula used in the original CDED protocol and is delivered for 6 weeks with individualized dietary counseling.
Annen: Modified Crohn's Disease Exclusion Diet (CDED)
Participants will follow a modified Crohn's Disease Exclusion Diet (CDED) adapted for patients with irritable bowel syndrome. The intervention excludes the enteral formula used in the original CDED protocol and is delivered for 6 weeks with individualized dietary counseling.
Aktiv komparator: Low FODMAP Diet
Participants randomized to this arm will follow a standard low FODMAP diet for 6 weeks with individualized dietary counseling.
Annen: Low FODMAP Diet
Participants will follow a standard low FODMAP diet for 6 weeks with individualized dietary counseling.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants achieving a clinically meaningful response (≥50-point reduction in IBS Symptom Severity Score [IBS-SSS])
Tidsramme: Baseline and Week 6
The primary efficacy outcome is the proportion of participants achieving a clinically meaningful response, defined as a reduction of at least 50 points from baseline in the IBS Symptom Severity Score (IBS-SSS) after 6 weeks of treatment. The IBS-SSS is a validated questionnaire ranging from 0 to 500, with higher scores indicating greater symptom severity.
Baseline and Week 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants achieving a ≥100-point reduction in IBS Symptom Severity Score (IBS-SSS)
Tidsramme: Baseline and Week 6
Proportion of participants achieving a reduction of at least 100 points from baseline in the IBS Symptom Severity Score (IBS-SSS) after 6 weeks of treatment.
Baseline and Week 6
Proportion of participants achieving a ≥50% reduction in IBS Symptom Severity Score (IBS-SSS)
Tidsramme: Baseline and Week 6
Proportion of participants achieving a reduction of at least 50% from baseline in the IBS Symptom Severity Score (IBS-SSS) after 6 weeks of treatment.
Baseline and Week 6
Change from baseline in IBS Symptom Severity Score (IBS-SSS)
Tidsramme: Baseline, Week 3, and Week 6
Absolute and percentage change from baseline in the IBS Symptom Severity Score (IBS-SSS). Scores range from 0 to 500, with higher scores indicating greater symptom severity.
Baseline, Week 3, and Week 6
Change from baseline in gastrointestinal symptom severity (Visual Analog Scale)
Tidsramme: Baseline, Week 3, and Week 6
Absolute and percentage change from baseline in gastrointestinal symptom severity assessed using a Visual Analog Scale (VAS), with higher scores indicating greater symptom severity.
Baseline, Week 3, and Week 6
Change in quality of life
Tidsramme: Baseline, Week 3, and Week 6
Change from baseline in IBS-specific quality of life measured using the IBS-Quality of Life questionnaire (IBS-QOL). Scores range from 0 to 100, with higher scores indicating better quality of life.
Baseline, Week 3, and Week 6
Change in psychological distress
Tidsramme: Baseline, Week 3, and Week 6
Change from baseline in psychological distress assessed using the Hospital Anxiety and Depression Scale (HADS), a validated 14-item questionnaire consisting of two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity. Total HADS score ranges from 0 to 42, with higher scores indicating greater overall psychological distress.
Baseline, Week 3, and Week 6
Change in extraintestinal symptoms
Tidsramme: Baseline, Week 3, and Week 6
Change from baseline in extraintestinal symptom burden assessed using a modified version of the Patient Health Questionnaire (PHQ-15), including 12 non-gastrointestinal items after exclusion of the three gastrointestinal symptom items (abdominal pain, constipation/diarrhea, and nausea/gas/indigestion). Each item is scored from 0 to 2, with higher scores indicating greater extraintestinal symptom burden.
Baseline, Week 3, and Week 6
Change in intestinal permeability measured by fecal α1-antitrypsin (A1AT)
Tidsramme: Baseline, Week 3, and Week 6
Change from baseline in fecal α1-antitrypsin concentration, a biomarker of intestinal permeability.
Baseline, Week 3, and Week 6
Change in fecal calprotectin concentration
Tidsramme: Baseline, Week 3, and Week 6
Change from baseline in fecal calprotectin concentration as a marker of intestinal inflammation.
Baseline, Week 3, and Week 6
Change in gut microbiota composition
Tidsramme: Baseline, Week 3, and Week 6
Change from baseline in gut microbiota composition and diversity assessed by 16S rRNA gene sequencing.
Baseline, Week 3, and Week 6
Participants' experiences with the dietary intervention
Tidsramme: Follow up: after completion of the 6-week intervention
Participants' perceptions, barriers, facilitators, and overall experiences with the assigned dietary intervention assessed through structured qualitative interviews.
Follow up: after completion of the 6-week intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ariel University

Samarbeidspartnere

Sheba Medical Center
Ministry of Innovation, Science and Technology of Israel

Etterforskere

  • Studiestol: Keren Hod, RD PhD, Ariel University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

7. juli 2026

Primær fullføring (Antatt)

30. juli 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

5. juli 2026

Først innsendt som oppfylte QC-kriteriene

12. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2495-25-SMC
  • 0009547 (Annet stipend/finansieringsnummer: Ministry of Innovation, Science and Technology, Israel)
  • 202540302 (Annen identifikator: Israel Ministry of Health)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Irritabel tarmsyndrom (IBS)

Kliniske studier på Modified Crohn's Disease Exclusion Diet (CDED)

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Albania

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere