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AbStats: Assessing Post-Prandial Intestinal Event Rates in Healthy Individuals

19 de febrero de 2019 actualizado por: Christopher Almario, Cedars-Sinai Medical Center

This study seeks to: Assess "normal" intestinal event rates for healthy subjects, to determine the effect of meal size on an individual's intestinal rate, and to determine whether there are differences between individuals in the fasting and post-prandial setting.

The investigators hypothesize the following:

  1. Fasting intestinal rate will be consistently less than 14 events per minute, similar to previously documented bowel sound frequency.
  2. There will a uniform increase in intestinal rate in the immediate post-prandial setting. There will be direct correlation between maximal and average post-prandial intestinal rates and meal size. Likewise, meal size will correlate with time to baseline fasting intestinal rate.
  3. Males and those with lower body mass index (BMI) will experience higher maximal and average post-prandial intestinal rates and shorter time to baseline fasting levels compared to females and those with higher BMI, respectively.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Participants will complete a baseline demographic and medical data sheet comprising of age, gender, race, ethnicity, height, weight, education, employment status, past medical history, and current prescription and over-the-counter medications. An AbStats device along with a log sheet will be provided to each subject, both of which will be returned upon completion of participation.

Upon waking, prior to oral intake, participants will place the AbStats disposable sensor on their abdomen and secure it using adhesive tape. The sensor is connected to a monitor which records the sounds collected by the sensors and interprets them to create and intestinal rate reading, measured as acoustic events per minute. The device will display a numerical intestinal rate reading, measured as acoustic events per minute. The device will display a numerical intestinal rate that participants will record on their personal log sheet. The purpose of this value is to assess the intestinal rate during fasting.

Participants will then eat a small standardized breakfast comprised of a thinkThin oatmeal single serve bowl, toasted English muffin with butter, and an 11oz iced coffee. No additions or substitutions are permitted in order to standardize the meal. The percent of food eaten will be recorded on the log sheet.

Lunch on Day 1 will be a "small meal" consisting of half of a turkey and Swiss Corner Bakery sandwich, cup of fruit, and 12oz can of diet soda. It will be eaten four to five hours after breakfast. No snacks are permitted between breakfast and lunch. Again, a pre-meal intestinal rate reading will be obtained 30 minutes prior to eating lunch; participants will secure the device onto the abdomen multiple times in order to gather post-prandial data. The intestinal rate will be recorded on the log sheet. The subject will record intestinal rate every 30 minutes for 5 hours after completion of the meal (e.g., lunch at 12 pm, then place sensors on abdomen for 10 minutes at 12:30 pm, 1:00 pm, 1:30 pm, 2:00 pm, 2:30 pm, 3:00 pm, 3:30 pm, 4: 00 pm, 4:30 pm, and 5:00 pm). Afterwards, participants can eat freely once these data points have been obtained. Dinner will be a meal of their choosing.

Day 2 of the study will be largely similar to Day 1: participants will measure fasting intestinal rate upon waking and will eat a standardized breakfast (see above). The main difference in Day 2 is that participants will eat a "large meal" for lunch consisting of a full turkey and Swiss Corner Bakery sandwich, cup of fruit, small bag of potato chips, small cookie, and a 12oz can of diet soda. The same pre- and post-lunch measurements notes above will be measured and recorded. By performing the above, investigators will assess preliminary intestinal rate measurements in the fasting state, after a small lunch (Day 1), and after a large lunch (Day 2).

Tipo de estudio

De observación

Inscripción (Actual)

25

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

    • California
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars-Sinai

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 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy subjects

Descripción

Inclusion Criteria:

  • Healthy adults aged 18 to 65 years
  • Able to provide consent

Exclusion Criteria:

  • Age younger than 18 or older than 65 years
  • Unable to provide consent
  • Vegetarian or vegan
  • Pregnant
  • Prior intestinal surgery
  • Recent gastroenteritis, diverticulitis or stool infection within past 3 months
  • Diagnosis of irritable bowel syndrome
  • Diagnosis of inflammatory bowel disorder (Crohn's disease, ulcerative colitis, indeterminate colitis, microscopic colitis, gastritis or enterocolitis).
  • Diagnosis of a malabsorption disorder: Celiac disease, protein losing enteropathy, pancreatic insufficiency, etc.
  • Diagnosis of autoimmune disorder: diabetes mellitus, scleroderma, undifferentiated connective tissue disorder, etc.
  • Diagnosis of motility disorder: achalasia, esophageal spasm, outlet obstruction, gastroparesis, chronic constipation, etc.
  • History of acute pancreatitis within past 3 months
  • History of GI malignancy (stomach, small or large intestine, pancreatic, neuroendocrine tumor, etc.)
  • Current or recent treatment with chemotherapy within past 3 months
  • History of radiation treatment
  • Current or recent use (within past month) of medications that either promote or decrease motility: opioids, cholinergic agonists, opioid antagonists, anti-diarrheals, pro-kinetic medications (e.g., metoclopramide, domperidone, erythromycin), etc.
  • Antibiotic use within 3 months
  • Diabetes mellitus with HgA1C >6.0

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

  • Modelos observacionales: Solo caso
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Healthy Participants
Potential participants will self-refer.
On Day 1 participants will record their intestinal rate at baseline fasting, pre-"small meal," and upon completion of the meal. On Day 2 participants will record their intestinal rate at baseline fasting, pre-"large meal," and upon completion of meal.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline fasting intestinal rate
Periodo de tiempo: 10 minutes
Prior to any oral intake, participants will record intestinal rate for 10 minutes
10 minutes
Pre-meal intestinal rate
Periodo de tiempo: 30 minutes prior to eating lunch participants will secure the device and record for 10 minutes
30 minutes prior to eating lunch participants will secure the device and record for 10 minutes
Post-prandial intestinal rate
Periodo de tiempo: Every 30 minutes for 5 hours after completion of meal
Every 30 minutes for 5 hours after completion of meal

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Christopher V. Almario, MD, MSHPM, Cedars-Sinai Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

1 de marzo de 2017

Finalización primaria (Actual)

17 de julio de 2017

Finalización del estudio (Actual)

17 de julio de 2017

Fechas de registro del estudio

Enviado por primera vez

7 de septiembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2016

Publicado por primera vez (Estimar)

20 de septiembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de febrero de 2019

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

19 de febrero de 2019

Última verificación

1 de febrero de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Pro00045465

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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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