A Study of How Common Bile Acid Malabsorption is in Patients with Diarrhea Predominant Irritable Bowel Syndrome

Overview

Información sobre este estudio

The purpose of this study is to assess how common bile acid malabsorption is in patients that have diarrhea predominant irritable bowel syndrome, by measuring blood samples for bile acids and abnormal levels of regulating hormones.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Prior diagnosis of IBS-D or functional diarrhea at Mayo Clinic will be specifically recruited and invited to participate
  • Patients with prior measurements of 48h total fecal bile acids or serum C4 will NOT be excluded
  • IBS symptoms positive by Rome III criteria 
  • Functional Diarrhea
    • Loose (mushy) or watery stools without pain occurring in at least 75% of stools
    • Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
  • Age 18-65 years 
  • Men or women
    • Ratio of 5 female to 1 male expected
    • Lactating women are eligible

 

Exclusion Criteria

  • Women who are currently pregnant are not eligible to participate due to changes in hepatic metabolism or cholestasis that may occur during pregnancy 
  • Use of drugs or agents within the past 1 week or planned use in the subsequent 10 days during the study period
    • Birth control pill, estrogen replacement therapy, metformin and thyroxine replacement are permissible exceptions
    • Agents that alter GI transit including opioids, narcotics, anticholinergics
    • Analgesic drugs including opiates and COX 2 inhibitors
    • Intake of medication that could interfere with the interpretation of the study
  • Abdominal surgery (except appendectomy) specifically, prior gastric surgery, vagotomy, cholecystectomy and any small bowel resection will be excluded
  • Known chronic liver disease or history of elevated AST/ALT 2.0 X ULN
  • BA synthesis and possible false positive or negative fecal bile acid or serum 7alphaC4 result
    • If there are no AST or ALT values in the medical record, the study physicians will determine if the tests need to be run

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Michael Camilleri, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20206539

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