Healthy Clinical Trial
Official title:
Evaluation of a New Method for Measuring Stool Consistency, Using a Texture Analyser (TA.XT Express Texture Analyser)
Verified date | November 2017 |
Source | Yakult Honsha European Research Center, ESV |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 6, 2017 |
Est. primary completion date | July 6, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in this trial. - Is treated (i.e., currently treated, treated within 1 month before inclusion) for constipation, diarrhoea or any other illness, by use of antibiotics or any other treatment with impact on defecation. - 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Onze-Lieve-Vrouw Hospital Aalst | Aalst |
Lead Sponsor | Collaborator |
---|---|
Yakult Honsha European Research Center, ESV | Harmony Clinical Research BVBA |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Bristol Stool Form Scale score | Bristol Stool Form Scale (BS) is for classifying the form of stool into 7 categories scored from 1 to 7; (1) Separate hard lumps like nuts (difficult to pass); (2) Sausage-shaped but lumpy; (3) Like a sausage but with cracks on its surface; (4) Like a sausage or snake, smooth and soft; (5) Soft blobs with clear-cut edges (passed easily); (6) Fluffy pieces with ragged edges, a mushy stool; (7) Watery, no solid pieces, entirely liquid. Subjects choose one of the BS scores which has a nearest analog form with their stools at every defecation. | Two stool collection periods of approximately 60 hours each | |
Secondary | Stool water content | Percentage of water in stool (weight/weight %) | Two stool collection periods of approximately 60 hours each | |
Secondary | Stool mucin | Concentration of mucin in stool | Two stool collection periods of approximately 60 hours each | |
Secondary | Stool pH | Degree of stool pH | Two stool collection periods of approximately 60 hours each | |
Secondary | Stool metabolites | Concentrations of stool metabolites including organic acids | Two stool collection periods of approximately 60 hours each | |
Secondary | Stool microbiota composition | Relative abundance of microbiota species (% of total) in stool | Two stool collection periods of approximately 60 hours each | |
Secondary | Stool amount | Weight (g) of stool produced in each defecation | Two stool collection periods of approximately 60 hours each | |
Secondary | Bowel habit | Presence or absence of straining during evacuation, presence or absence of sensation of remaining stool in the rectum after evacuation | Two stool collection periods of approximately 60 hours each | |
Secondary | Sleep habit | Getting-up time, going-to-bed time and sleeping hours | Two stool collection periods of approximately 60 hours each |
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