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Decentralized Dietary UC Pilot Trial

5 de noviembre de 2015 actualizado por: Transparency Life Sciences

A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis

This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study.

Descripción general del estudio

Estado

Desconocido

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

51

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Massachusetts
      • Brookline, Massachusetts, Estados Unidos, 02467
        • Reclutamiento
        • Crohn's and Colitis Center at Brigham and Women's Hospital
        • Investigador principal:
          • Joshua Korzenik, MD
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.
  2. Ability and willingness to provide documented informed consent and to comply with the study procedures, including in-person visits for Arm 1 and video visits for Arm 2.
  3. Documented history of moderate to severe active UC
  4. Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)
  5. Screening fecal calprotectin>350 mg/g
  6. Diagnosis of moderately to severely active UC, including historical endoscopy sub score ≥2; a rectal bleeding sub score ≥1 and disease activity a minimum of 25 cm from the anal verge.
  7. Documented (via video or report) endoscopy performed within 2 years prior to randomization.
  8. Access to a computer or mobile device with internet connection and an active email address.

Exclusion Criteria:

  1. Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
  2. Past or present ileostomy or colostomy
  3. Short bowel syndrome
  4. Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon
  5. Past or present fistula or abdominal abscess
  6. History or current evidence of colonic mucosal dysplasia
  7. Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued ≥3 weeks prior to study enrollment
  8. Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study
  9. Crohn's Disease
  10. Significant uncontrolled co-morbidity, such as neurological, cardiac (e.g., moderate to severe heart failure NYHA class III/IV), pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
  11. History of alcohol, drug or chemical abuse within 6 months prior to screening
  12. Pregnant females, those intending to become pregnant, and those who are lactating
  13. Current participation in any other clinical trial

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Traditional

Subjects in Study Arm 1 will undergo a screening process, and if randomized, will follow a traditional, site-based clinical trial model and undergo a baseline visit and 3 more in-person visits with the Principal Investigator (total of 4 visits).

Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).

The CAID requires participants to modify their diet to include certain types of foods that may have anti-inflammatory properties. Participants on the CAID will be required to abstain from red meat and alcoholic beverages.
Comparador activo: Remote

Subjects in Study Arm 2 will undergo a screening process, and if randomized, will undergo one Baseline visit at the local Gastroenterologist's office and 4 video visits with the Principal Investigator. A mobile nurse will visit subjects at a distant location (such as their home) to obtain blood samples at visits 1 and 4.

Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).

The CAID requires participants to modify their diet to include certain types of foods that may have anti-inflammatory properties. Participants on the CAID will be required to abstain from red meat and alcoholic beverages.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Periodo de tiempo: Week 1
Comparison of the proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score between Study Arms 1 and 2.
Week 1
Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
Periodo de tiempo: Week 7
Comparison of the proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study between Study Arms 1 and 2.
Week 7
Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
Periodo de tiempo: Weeks 0, 5 and 7
Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
Weeks 0, 5 and 7

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Periodo de tiempo: Weeks 1 and 7
Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).
Weeks 1 and 7
Adverse Events
Periodo de tiempo: Weekly through week 11
Difference in incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) between Study Arms 1 and 2 and between Control and CAID (dietary intervention) arms.
Weekly through week 11
Dietary Compliance Comparison
Periodo de tiempo: Week 7
Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.
Week 7
Participant Satisfaction Survey
Periodo de tiempo: Week 7
Difference in reported patient satisfaction with trial participation between arms 1 and 2.
Week 7
Mayo Score Discrepancy Frequency
Periodo de tiempo: Week 7
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.
Week 7
Physician's Global Assessment Discrepancy Frequency
Periodo de tiempo: Week 7
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.
Week 7

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Tomasz Sablinski, MD, PhD, Transparency Life Sciences

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2015

Finalización primaria (Anticipado)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

23 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

2 de febrero de 2015

Publicado por primera vez (Estimar)

6 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de noviembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2015

Última verificación

1 de noviembre de 2015

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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