Stool consistency Digestive System
Conditions
Interventions
Sixty four healthy subjects who frequently produce hard stool (Bristol Stool Form Scale score 1 and 2 stools with the frequency of 50% or more during 2 weeks of the screening data collection period) w
Sponsors
Yakult Honsha European Research Centre for Microbiology ESV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any study-related activities 2. Healthy female or male aged 18–65 years (inclusive) 3. Produces hard stool (BS1 and 2 stools), with a frequency of 50% or more during 2 weeks of screening data period 4. Does not take probiotics 2 weeks before the start of screening data collection. If the patient takes probiotics, a washout period of 2 weeks is needed 5. Is willing and able to collect every stool at home during 3 consecutive days and this 3 times during the treatment period, to store the samples in appropriate conditions and to return the samples within the required timeframe 6. Is willing and able to complete a diary during the screening, baseline and treatment period in order to collect information about the form of the stools (based on the Bristol Stool Form Scale classification) and bowel habit 7. Prepared not to change the current drinking, eating, smoking and exercising habits during the course of the study 8. Understands the Dutch or English language (reading, writing, speaking)
Exclusion criteria
Exclusion criteria: 1. Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in the study 2. Is vegetarian or vegan 3. Is treated (i.e., currently treated, treated within 1 month before screening) by a doctor for her/his constipation 4. Has any history of gastrointestinal surgery except for appendectomy 5. Has any history of chronic/severe gastrointestinal disorders 6. Females of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods (e.g., oral contraceptive, condom, intrauterine device, abstinence) 7. Is unable to refrain from or anticipates the use of antibiotics and/or laxatives 8. Has any history of drug and/or alcohol abuse 9. Has milk allergies 10. Is intolerant to lactose 11. 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 12. Use of disallowed concomitant medications and concomitant products within 2 weeks before the screening period, depending if a wash out period for probiotics is needed 13. Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the Investigator’s opinion could interfere with the results of the study 14. Previous participation in this study. Participation is defined as screened. Re-screening is therefore not allowed 15. Participation in another interventional clinical study or receipt of any investigational product within 1 month before the screening period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool consistency measured by the texture analyser (TA.XT Express Texture Analyser) before consumption of investigational product (IP), and 4 and 8 weeks after starting IP consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bowel habit and stool consistency measured using the Bristol Stool Form Scale score for all defecations using online questionnaire from after allocation until the end of the study Measured from stool samples collected before consumption of investigational product (IP), and 4 and 8 weeks after starting IP consumption: 2. Stool amount measured by weighing 3. Stool water content measured by subtracting dried stool weight from raw stool weight 4. Stool pH measured directly using pH meter InLab®Solids 5. Stool mucin, stool lipids and stool bile acids measured by commercial ELISA kits 6. Stool microbiota analyzed by 16S rRNA sequencing method 7. Stool organic acids and stool putrefactive substances measured by High Performance Liquid Chromatograph (HPLC) | — |
Countries
Belgium
Outcome results
None listed