- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03035799
Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
- Other causes of bowel symptoms excluded to the satisfaction of the Study Team
- Age at least 18 years at initial screening visit
- Patients who are able to sign and understand the study's informed consent form
- Patients able to complete all screening evaluations and procedures
Exclusion Criteria:
- Patients in inpatient hospital care
- Severe or refractory bowel or psychological symptoms
- Current consumption of a Paleolithic diet
- Known Celiac disease
- Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
- Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
- Patients unable to speak English
- Inability to obtain informed consent
- Pregnant or nursing women
- Any condition, which in the opinion of the investigator, would interfere with study requirements
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Paleolithic Diet
|
Paleolithic diet
|
Comparador activo: General Healthful Diet
|
General Healthful Diet
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Vitality
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Vitality as measured on the vitality subscale of the short form health survey (SF36).
This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys.
The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life?
Did you have a lot of energy?
Did you feel worn out?
Did you feel tired?
The lower the score the more disability.
The higher the score the less disability.
|
The change between baseline and 4 weeks (post-intervention).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Anxiety
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
|
Depression
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire. PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
|
Activity level
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire.
The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise.
It is designed to be reliable valid and easy to complete quickly without a need for detailed review.
Lower scores indicate less activity and higher scores equal more activity.
|
The change between baseline and 4 weeks (post-intervention).
|
Gastrointestinal symptoms
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
|
Visceral sensitivity
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Visceral sensitivity as measured by the Visceral Sensitivity Index.
Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
|
The change between baseline and 4 weeks (post-intervention).
|
Overall health status (Short Health Scale)
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Overall health status as measured by the Short Health Scale questionnaires.
The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
|
The change between baseline and 4 weeks (post-intervention).
|
Overall health status (EQ-5D)
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression.
Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive
system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
|
The change between baseline and 4 weeks (post-intervention).
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Intestinal permeability
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Change in intestinal permeability as measured by plasma zonulin levels
|
The change between baseline and 4 weeks (post-intervention).
|
Change in inflammatory markers
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Change in inflammatory markers as measured by serum C-reactive protein levels
|
The change between baseline and 4 weeks (post-intervention).
|
Change in stool metabolomics
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Change in stool metabolomics as measured by stool metabolite testing.
|
The change between baseline and 4 weeks (post-intervention).
|
Change in stool microbiome profile
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of urine.
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool.
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of saliva.
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of blood.
Periodo de tiempo: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00082222
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.
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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