Evaluation of New Method for Measuring Stool Consistency

NCT03188302 | Completed

• 1 other identifier: YHER16-TAXT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stool consistency; Texture Analyser; Bristol Stool Form Scale

Outcome Measures

Primary Outcomes (1)

• Stool consistency

  Stool consistency is measured as force (g) during compression by Texture Analyser. A cylinder probe is put vertically into the object with a constant speed and the force is measured when reaching down to the target (5 mm down from the surface) as an outcome.

  Two stool collection periods of approximately 60 hours each

Secondary Outcomes (9)

• Bristol Stool Form Scale score

  Two stool collection periods of approximately 60 hours each

• Stool water content

  Two stool collection periods of approximately 60 hours each

• Stool mucin

  Two stool collection periods of approximately 60 hours each

• Stool pH

  Two stool collection periods of approximately 60 hours each

• Stool metabolites

  Two stool collection periods of approximately 60 hours each

Study Arms (1)

Specimen collection

OTHER

Collection of stool samples

Other: Collection of stool samples

Interventions

Collection of stool samples OTHER

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.

Specimen collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any study-related activities.
• Healthy female or male aged 18 years (inclusive) or older.
• Is willing and able to provide at least 3 stool samples during 2 collection periods of approximately 60 hours, to store the samples in appropriate conditions and to return the samples within the required timeframe.
• Is willing and able to complete a diary during the stool collection periods in order to collect information about form of the stools (based on the Bristol Stool Form Scale classification), bowel habit and sleep habit.
• Understands the Dutch or English language (reading, writing, speaking).

You may not qualify if:

• Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in this trial.
• Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant.
• Is unable to refrain from or anticipates the use of disallowed medications, e.g., antibiotics, laxatives, anti-diarrheal medication.
• Has any history of drug and/or alcohol abuse.
• Any clinically significant disease which in the Investigator's opinion could interfere with the safety of study participants or with the results of the study.
• Participation in another interventional clinical study or receipt of any investigational product within 1 month before visit 1.

Sponsors & Collaborators

• Yakult Honsha European Research Center, ESV: lead
• Harmony Clinical Research BVBA: collaborator

Study Sites (1)

Onze-Lieve-Vrouw Hospital Aalst

Aalst, 9300, Belgium

Location

Study Officials

• Ignace Demeyer, Dr.

  Onze-Lieve-Vrouw Hospital Aalst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 15, 2017
• Study Start: June 2, 2017
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)