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Proposal Evaluating Time-specific Relationships Between Variables of Pain, Stress, and Bloating in IBS Diarrhea and Constipation Symptoms Using a Palm Pilot

NCT00619125 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2017-06-20

No results posted yet for this study

Summary

Purpose: The associations between pain, stress, bloating, and their short interval temporal relationships to defecation in IBS D, C \& M are of great interest to the field of functional GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over past week or month) of pain and bloating have been key features of the diagnosis of IBS, however such long term retrospective recall of symptom experience has been shown to be unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval assessment may provide a more accurate picture of patient symptom experience Participants: Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study participants could be asked to record data at randomly assigned points throughout the day, as well as during the course of a diarrheal or constipated stool (i.e., prior to and right after a bowel movement).

Conditions

  • IBS, Diarrhea Predominant
  • IBS, Constipation Predominant
  • IBS, Mixed Symptoms

Interventions

OTHER

palm pilot recording responses to questionnaires

Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.

Sponsors & Collaborators

  • Takeda Pharmaceuticals North America, Inc.

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Douglas Drossman, MD · UNC-Chapel Hill

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-03-31
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00619125 on ClinicalTrials.gov