Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Abigail Raffner, RD PhD
- Número de teléfono: 216-327-6003
- Correo electrónico: Abigail.Raffner@uhhospitals.org
Copia de seguridad de contactos de estudio
- Nombre: Sargun Singh, M.B.B.S.
- Número de teléfono: 216-333-6085
- Correo electrónico: sargun.singh@uhhospitals.org
Ubicaciones de estudio
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Ohio
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Chagrin Falls, Ohio, Estados Unidos, 44122
- Reclutamiento
- UH Minoff Health Center
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Sub-Investigador:
- Jeffry Katz, MD
-
Contacto:
- Abigail Basson, RD PhD
- Correo electrónico: Abigail.Basson@uhhospitals.org
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Cleveland, Ohio, Estados Unidos, 44106
- Reclutamiento
- University Hospitals Cleveland Medical Center
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Sub-Investigador:
- Jeffry Katz, MD
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Contacto:
- Abigail Basson, RD PhD
- Correo electrónico: Abigail.Basson@uhhospitals.org
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Sub-Investigador:
- Vu Nguyen, MD
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Westlake, Ohio, Estados Unidos, 44145
- Reclutamiento
- UH Westlake Health Center
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Contacto:
- Abigail Basson, RD PhD
- Correo electrónico: Abigail.Basson@uhhospitals.org
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Sub-Investigador:
- Vu Nguyen, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in fecal microbiome measured by metagenome analysis
Periodo de tiempo: Baseline, three weeks pre-intervention, and three weeks after intervention
|
Quantify the change in the fecal microbiome using metagenome analysis
|
Baseline, three weeks pre-intervention, and three weeks after intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Fecal Myeloperoxidase activity (MPO)
Periodo de tiempo: Baseline, three weeks pre-intervention, three weeks post-intervention
|
Quantify the change in fecal MPO
|
Baseline, three weeks pre-intervention, three weeks post-intervention
|
|
Change in Fecal Calprotectin
Periodo de tiempo: Baseline, three weeks pre-intervention, three weeks post-intervention
|
Quantify the change in fecal calprotectin
|
Baseline, three weeks pre-intervention, three weeks post-intervention
|
|
Change in Crohn's Disease Activity Index (CDAI)
Periodo de tiempo: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
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)
Periodo de tiempo: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
|
Quantify change in CRP
|
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fabio Cominelli, MD PhD, University Hospitals Cleveland Medical Center
- Investigador principal: Abigail Raffner, RD PhD, Case Western Reserve University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY20221141
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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