The Inflammatory Bowel Disease Mediterranean Diet (IBDMED) Microbiome-targeting Nutritional Education Program (IBDMED)
8 septembre 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Lihi Godny, PhD
- Numéro de téléphone: +97237525015
- E-mail: lihigodny@gmail.com
Lieux d'étude
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Hyderabad, Inde
- Recrutement
- Asian Institute of Gastroenterology
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Contact:
- Rupa Banerjee, Dr
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Petah Tikva, Israël
- Recrutement
- Rabin Medical Center
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Contact:
- Lihi Godny, PhD
- Numéro de téléphone: +97237525015
- E-mail: lihigodny@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Composite biological score
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical and inflammatory response
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Microbial outcomes- alpha diversity
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 septembre 2022
Achèvement primaire (Anticipé)
1 mai 2023
Achèvement de l'étude (Anticipé)
1 décembre 2024
Dates d'inscription aux études
Première soumission
1 septembre 2022
Première soumission répondant aux critères de contrôle qualité
8 septembre 2022
Première publication (Réel)
13 septembre 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 septembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2022
Dernière vérification
1 septembre 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0359-21
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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