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Evaluation of New Method for Measuring Stool Consistency

NCT03188302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-09

No results posted yet for this study

Summary

This study is designed to validate a new direct method for the measurement of stool consistency, using Texture Analyser. Forty healthy subjects are enrolled in this trial for collection of stool samples. Every stool produced during 2 collection periods of approximately 60 hours each is collected and subjected to the measurement of consistency using Texture Analyser. The stool consistency results are compared with the Bristol Stool Form Scale scores for each stool. The relationships of stool consistency with other stool parameters, bowel habit and sleeping habit are also evaluated.

Conditions

  • Healthy

Interventions

OTHER

Collection of stool samples

The subjects collect stool samples to be used for validation of a new direct measurement of stool consistency. Every stool sample produced during 2 collection periods of approximately 60 hours each have to be collected using the Commode Specimen Collection System (Medline Industries, Inc.). Each collection period starts preferably in the evening (20h00) and ends 3 days later in the morning (08h00). The collected samples must be stored at subject's home in a refrigerator provided by the sponsor until handover to the site staff.

Sponsors & Collaborators

  • Harmony Clinical Research BVBA

    collaborator OTHER

  • Yakult Honsha European Research Center, ESV

    lead OTHER

Principal Investigators

  • Ignace Demeyer, Dr. · Onze-Lieve-Vrouw Hospital Aalst

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2017-07-06
Completion
2017-07-06

Countries

  • Belgium

Study Locations

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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 NCT03188302 on ClinicalTrials.gov