The Inflammatory Bowel Disease Mediterranean Diet (IBDMED) Microbiome-targeting Nutritional Education Program (IBDMED)
8. september 2022 oppdatert av: IRIS DOTAN, Rabin Medical Center
The Inflammatory Bowel Disease Mediterranean Diet (IBDMED) Microbiome-targeting Nutritional Education Program for CD Control and Prevention
The rising incidence of Crohn's disease (CD) and ulcerative colitis (UC), especially in the newly industrialized nations of Asia, highlights the possible role of environmental triggers such as diet and the gut microbiome in the pathogenesis of inflammatory bowel diseases (IBD). The Mediterranean diet (MED) has been previously correlated with beneficial outcomes in several chronic and immune-mediated diseases and has been linked with positive outcomes in IBD. However, consumption of high fiber foods like fruits, vegetables, whole grains, legumes and nuts may be challenging for patients with IBD without tight dietary guidance and support.
The IBDMED nutritional education program aims to improve the adherence of patients with IBD to MED. Patients are educated on how to implement and incorporate MED principles into their daily lifestyle, by providing information, tips, practical tools, cooking methods and recipes, that are available on an interactive website and application. Patients are monitored for their diet, sleep, physical activity and stress levels via fitness trackers and questionnaires developed for this study and receive feedback and personal recommendations from the study dietitians along the way.
This RCT will assess the feasibility and effects of an 8-week IBDMED nutritional and lifestyle education program vs. the nutritional standard of care in patients with newly diagnosed CD and in healthy subjects in Israel and India.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Lihi Godny, PhD
- Telefonnummer: +97237525015
- E-post: lihigodny@gmail.com
Studiesteder
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Hyderabad, India
- Rekruttering
- Asian Institute of Gastroenterology
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Ta kontakt med:
- Rupa Banerjee, Dr
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Petah Tikva, Israel
- Rekruttering
- Rabin Medical Center
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Ta kontakt med:
- Lihi Godny, PhD
- Telefonnummer: +97237525015
- E-post: lihigodny@gmail.com
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-
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
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients with early CD, defined as up to 12 months from diagnosis
- Inflammatory (B1) phenotype, specifically-no known fibrostenotic (B2) or internal penetrating (B3) disease. No known perianal disease (p). Any CD location will be included (L1-4)
- Patients with mild CD as measured by HBI 5-7 or CDAI 150-220 or patients with HBI<5 or CDAI<150 with at least one additional objective measure of inflammation: 1. inflammatory biomarkers: elevated CRP or fecal calprotectin at enrollment; active disease by endoscopy or VCE performed up to 12 weeks prior to enrollment; active inflammation demonstrated by imaging (CTE, MRE, IUS) performed up to 12 weeks prior to enrollment.
- Any stable concomitant CD therapy is allowed. 5-ASA (stable dose for at least 2 weeks), steroids (budesonide or any non topical corticosteroids)-stable dose for at least 2 weeks: prednisone up to 20 mg/day or budesonide up to 6 mg/day; immunomodulators (stable dose for 8 weeks) and/ or anti-TNFs at least 4 weeks after the end of induction or any optimization; anti integrins at least 4 weeks after the end of induction or any optimization; anti IL12/IL23 at least 4 weeks after the end of induction or any optimization; None of the above. For inclusion in a non-steroid group, a 2-week washout period will be required.
- TB evaluation was done in the Indian population
- For India-Hindi/Telugu speakers
- Willing and able to sign an informed consent form
- Willing and able to participate and adhere to IBDMED program
Exclusion Criteria:
- Pregnant women
- Diabetes mellitus
- Any previous gastrointestinal surgery (except appendectomy)
- Antibiotic therapy during the 4 weeks prior to enrollment. After enrollment, a non-CD short course of antibiotics will be allowed, if prescribed
- Any concomitant disease or treatment that according to the treating physician considerations interferes with patient safety or study outcomes (specifically-uncontrolled thyroid disease, renal failure)
- Undernutrition or need for enteral nutrition supplementation according to the treating dietitian
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: IBDMED-ISR
Patients with newly diagnosed CD in Israel
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The IBDMED program will be applied for 8 weeks and include education on MED diet and lifestyle components, focused on increasing and diversifying dietary fiber intake, reduction of ultra-processed food intake and promoting an active lifestyle.
This intervention is digitally supported by an interactive website application and step trackers to monitor lifestyle parameters.
Dietary counseling according to the local dietary guidelines for patients with IBD
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Annen: IBDMED-IND
Patients with newly diagnosed CD in India
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The IBDMED program will be applied for 8 weeks and include education on MED diet and lifestyle components, focused on increasing and diversifying dietary fiber intake, reduction of ultra-processed food intake and promoting an active lifestyle.
This intervention is digitally supported by an interactive website application and step trackers to monitor lifestyle parameters.
Dietary counseling according to the local dietary guidelines for patients with IBD
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Composite biological score
Tidsramme: 8 weeks
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A composite biological score comprised of changes in clinical (HBI/CDAI), inflammatory (CRP/calprotectin) and microbial (diversity, MDI) indices.
A decrease in clinical indices, inflammatory markers or MDI will be considered positive and will be scored as follows: -10%: +1 point, -20%: +2 points, -30%: +3 points; An increase in microbial diversity will be considered positive and will be scored as follows: +10%: +1 point, +20%: +2 points, +30%: +3 points.
The composite biological score ranges between 0-15 points.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical and inflammatory response
Tidsramme: 8 weeks
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Decrease in inflammatory activity: at least 30% decrease in HBI and/or CDAI and the additional inflammatory biomarker used at inclusion.
In any case where CRP or fecal calprotectin were elevated, they will be used to evaluate decreased activity.
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8 weeks
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Improvement in quality of life
Tidsramme: 8 weeks
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Improved quality of life as assessed by the PRO2 (≥50% or ≥ 4 points)
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8 weeks
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Dietary adherance
Tidsramme: 8 weeks
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Adherence to IBDMED in India and Israel-measured by IBDMED score.
The IBDMED adherance screener includes 11 items and ranges between 0-30.
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8 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Microbial outcomes- alpha diversity
Tidsramme: 8 weeks
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Microbial diversity will be compared between groups and intra-individual changes will be assessed using paired analysis.
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8 weeks
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Microbial outcomes- Microbial dysbiosis index
Tidsramme: 8 weeks
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MDI will be compared between groups and intra-individual changes will be assessed using paired analysis.
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8 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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 (Forventet)
1. september 2022
Primær fullføring (Forventet)
1. mai 2023
Studiet fullført (Forventet)
1. desember 2024
Datoer for studieregistrering
Først innsendt
1. september 2022
Først innsendt som oppfylte QC-kriteriene
8. september 2022
Først lagt ut (Faktiske)
13. september 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. september 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2022
Sist bekreftet
1. september 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0359-21
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