Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease

Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial

Patrocinadores

Patrocinador principal: University of British Columbia

Colaborador: The Alfred
Melbourne Health

Fuente University of British Columbia
Resumen breve

The investigators hypothesize that a novel method for oligosaccharide supplementation, in the form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS), will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD) in remission.

Descripción detallada

Subjects age >/= 19 years with the diagnosis of CD for >/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (

The study is a randomized, double-blind, placebo-controlled trial that consist of a 2-week run-in period followed by a 4-week study period. Prior to study entry, a screening visit will be required for all potential participants. If a participant meets the inclusion criteria, they will be randomized to either a placebo (0.55 g total fructans/GOS), a moderate oligosaccharide group (3.25 g total fructans/GOS) or a high oligosaccharide group (5.43 g total fructans/GOS) through a computed-generated scheme within each respective center. During the run-in period, enrolled subjects will undergo the following: 1) Laboratory analyses (CBC, routine biochemistry, CRP and fecal calprotectin); 2) Stool collection for fecal calprotectin analysis; 3) tolerability assessment including overall gastrointestinal symptoms and specific symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) utilizing a 100mm visual analogue scale (VAS, 0 = no symptoms; 100 = worst symptoms ever experienced); 4) fatigue assessment utilizing a multi-dimensional fatigue impact scale (FIS); 5) health-related quality of life (HRQOL) assessment utilizing the Short Form 36-Item Health Survey (SF-36) and 6) Mood assessment utilizing the Spielberger State-Trait Personality Inventory (STPI). Participants will also meet with a registered dietitian to quantify baseline oligosaccharide consumption by completing a prospective 5-day diet diary alongside a validated food frequency questionnaire (FFQ), the Monash University Comprehensive Nutritional Assessment Questionnaire (CNAQ) that assesses oligosaccharide intake in addition to the usual nutrients [49]. Once the initial dietary assessment is complete, participants will begin up-titration of their oligosaccharide supplementation in a step-wise fashion until they reach their required daily amounts defined by their treatment group allocation. Once this is achieved, they will enter the 4 weeks of treatment or at time of relapse. Participants will undergo re-assessment during the study period at 2 weeks (Visit #3), and at study completion (Visit #4).

If a participant undergoes a CD flare during the run-in period, they will be withdrawn from the study. The end point of the study will be at 4 weeks of treatment or at time of relapse.

Estado general Unknown status
Fecha de inicio August 2015
Fecha de Terminación December 2018
Fecha de finalización primaria May 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Difference in overall GI symptoms 5 days
Resultado secundario
Medida Periodo de tiempo
Tolerability 4 weeks
Fatigue assessment 4 weeks
Quality of Life Assessment 4 weeks
Mood Assessment 4 weeks
Disease Activity Asessment 4 weeks
Adherence Assessment 4 weeks
Inscripción 48
Condición
Intervención

Tipo de intervención: Dietary Supplement

Nombre de intervención: Placebo

Descripción: 1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)

Etiqueta de grupo de brazo: Placebo

Tipo de intervención: Dietary Supplement

Nombre de intervención: Moderate Oligosaccharide Group

Descripción: 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)

Etiqueta de grupo de brazo: Moderate Oligosaccharide Group

Tipo de intervención: Dietary Supplement

Nombre de intervención: High Oligosaccharide Group

Descripción: 1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)

Etiqueta de grupo de brazo: High Oligosaccharide Group

Elegibilidad

Criterios:

Inclusion Criteria:

- age >/= 19 years

- diagnosed with CD for >/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (

Exclusion Criteria:

- unable to provide informed consent;

- have significant hepatic, renal, endocrine, respiratory, neurological, or cardiovascular disease;

- confirmed diagnosis of celiac disease, or have suspected celiac disease and are following a gluten-free diet to manage symptoms with an elevated screening anti-tissue transglutaminase antibody test;

- significant complications of CD which includes a history of extensive colonic resection, including subtotal or total colectomy, history of >/= 3 small bowel resections or received a diagnosis of short bowel syndrome, current ileostomy, colostomy or ileal-anal pouch, or a fixed symptomatic intestinal stenosis;

- antibiotic use in the 4 weeks prior to study start;

- use of any rectal preparations in the 2 weeks prior to study start;

- use of any non-steroidal anti-inflammatory drugs in the 2 weeks prior to study start;

- use of commercial probiotic supplements in the 4 weeks prior to study start

- change in CD therapy in the 4 weeks prior to study start (excluding steroid taper, however steroid dosing must be stable for 2 weeks prior to study start);

- recently been adhering to a novel dietary intervention for alternative health issues within the last 4 weeks prior to study start.

Género: All

Edad mínima: 19 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Cherry E. Galorport

Teléfono: 604-806-9440

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador:
Department of Gastroenterology Alfred Hospital | Melbourne, Australia Recruiting Julie Hogg +61 3 90760182 Peter Gibson, MD Sub-Investigator Jane Muir, PhD Sub-Investigator Jacqueline Barrett, PhD Sub-Investigator
GI Clinic, St. Paul's Hospital | Vancouver, British Columbia, V6Z 1Y6, Canada Recruiting Cherry Galorport 604-806-9440 [email protected] Brian Bressler, MD Principal Investigator Ashley Charlebois, RD, MsC Sub-Investigator Amee Manges, PhD Sub-Investigator Greg Rosenfeld, MD Sub-Investigator Neal Shahidi, MD Sub-Investigator
Ubicacion Paises

Australia

Canada

Fecha de verificación

March 2018

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of British Columbia

Nombre completo del investigador: Brian Bressler

Título del investigador: Clinical Associate Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: 1 placebo muesli bars and 1 serving placebo muesli per day (0.55 g total fructans/GOS)

Etiqueta: Moderate Oligosaccharide Group

Tipo: Experimental

Descripción: 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)

Etiqueta: High Oligosaccharide Group

Tipo: Experimental

Descripción: 1 intervention muesli bar and 1 serving intervention muesli per day (5.43 total fructans/GOS)

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Factorial Assignment

Propósito primario: Other

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov