Clinical trial NCT03188302: Evaluation of New Method for Measuring Stool Consistency
Official title: Evaluation of a New Method for Measuring Stool Consistency, Using a Texture Analyser (TA.XT Express Texture Analyser)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Stool consistency
Texture Analyser
Bristol Stool Form Scale
Lead sponsor: Yakult Honsha European Research Center, ESV
Sponsor class: OTHER
Collaborators: name: Harmony Clinical Research BVBA
First posted: 2017-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: It is now obvious that the proper functioning of the gastrointestinal tract has a positive effect on the quality of life. Normal bowel habits vary considerably from person to person with regard to frequency of bowel movements, and bulk and consistency of stools. Constipation is the common digestive complaint in European populations, and softening stool consistency can be regarded as beneficial for such population in terms of reducing incidence of hard or lumpy stools .

The Bristol Stool Form Scale (BS) is validated as a surrogate measure for gastrointestinal transit time, and has been also applied to an evaluation of stool consistency. Subjects compare their stool with the BS chart consisting of seven categories and choose one score which has a nearest analog form. The BS has been widely used in the studies to evaluate changes in stool consistency after dietary intervention using probiotics and/or prebiotics. However, there is a lack of evidence in the validity of BS to yield consistent and reproducible estimates of changes in stool consistency over time. In order to obtain a closer estimate of its change, it would be preferred to use a more directly observable and objective parameter or combination of parameters.

From the above mentioned backgrounds, this study is conducted to validate a new direct method for the measurement of stool consistency, using Texture Analyser: TA.XTExpress Texture Analyser (Stable Micro Systems Ltd.).

Eligibility criteria: 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.

Primary outcomes:
measure: Stool consistency
timeFrame: Two stool collection periods of approximately 60 hours each
Secondary outcomes:
measure: Bristol Stool Form Scale score
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Stool water content
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Stool mucin
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Stool pH
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Stool metabolites
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Stool microbiota composition
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Stool amount
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Bowel habit
timeFrame: Two stool collection periods of approximately 60 hours each
measure: Sleep habit
timeFrame: Two stool collection periods of approximately 60 hours each
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouw Hospital Aalst
Study officials:
affiliation: Onze-Lieve-Vrouw Hospital Aalst
name: Ignace Demeyer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: