Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).
Fecal & urine samples will be collected before/after each phase. Blood will also be collected.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Abigail Raffner, RD PhD
- Numéro de téléphone: 216-327-6003
- E-mail: Abigail.Raffner@uhhospitals.org
Sauvegarde des contacts de l'étude
- Nom: Sargun Singh, M.B.B.S.
- Numéro de téléphone: 216-333-6085
- E-mail: sargun.singh@uhhospitals.org
Lieux d'étude
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Ohio
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Chagrin Falls, Ohio, États-Unis, 44122
- Recrutement
- UH Minoff Health Center
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Sous-enquêteur:
- Jeffry Katz, MD
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Contact:
- Abigail Basson, RD PhD
- E-mail: Abigail.Basson@uhhospitals.org
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Cleveland, Ohio, États-Unis, 44106
- Recrutement
- University Hospitals Cleveland Medical Center
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Sous-enquêteur:
- Jeffry Katz, MD
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Contact:
- Abigail Basson, RD PhD
- E-mail: Abigail.Basson@uhhospitals.org
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Sous-enquêteur:
- Vu Nguyen, MD
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Westlake, Ohio, États-Unis, 44145
- Recrutement
- UH Westlake Health Center
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Contact:
- Abigail Basson, RD PhD
- E-mail: Abigail.Basson@uhhospitals.org
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Sous-enquêteur:
- Vu Nguyen, MD
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Age range from: 18 to 70 years. Male or female. Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (<6 score).
Capable of providing consent to participate. Able to complete daily surveys and take oral nutrition. Able to record meal intake. Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).
Exclusion Criteria:
Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
Known drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture/narrowing. Presence of an ostomy. Known active malignancy. Antibiotic use within last 14 days. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of <1 natural bowel movements per 3 consecutive days. Unable to access to technology that permits the daily completion of study related activities.
Change in IBD medication within past 4 weeks. Body mass Index <18 kg/m or ≥35 kg/m. Documented C.difficile colitis within four weeks of screening. Bariatric surgery Phenylketonuria
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Crohn's participants
Crohn's participants will consume artificial sweetener: sucralose
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Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
|
|
Expérimental: Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose
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Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in fecal microbiome measured by metagenome analysis
Délai: Baseline, three weeks pre-intervention, and three weeks after intervention
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Quantify the change in the fecal microbiome using metagenome analysis
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Baseline, three weeks pre-intervention, and three weeks after intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Fecal Myeloperoxidase activity (MPO)
Délai: Baseline, three weeks pre-intervention, three weeks post-intervention
|
Quantify the change in fecal MPO
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Baseline, three weeks pre-intervention, three weeks post-intervention
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Change in Fecal Calprotectin
Délai: Baseline, three weeks pre-intervention, three weeks post-intervention
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Quantify the change in fecal calprotectin
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Baseline, three weeks pre-intervention, three weeks post-intervention
|
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Change in Crohn's Disease Activity Index (CDAI)
Délai: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
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Quantify the change in Crohn's Disease Activity Index.
The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity.
It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation.
Each component is multiplied by a specific weighting factor and summed to calculate a total score.
Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity.
A score of <150 indicates clinical remission, while a score of >450 indicates severe disease.
A negative change from baseline indicates clinical improvement.
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Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
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Change in C-reactive protein (CRP)
Délai: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
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Quantify change in CRP
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Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Fabio Cominelli, MD PhD, University Hospitals Cleveland Medical Center
- Chercheur principal: Abigail Raffner, RD PhD, Case Western Reserve University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY20221141
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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