Healthy individuals who frequently produce hard stools Digestive System
Conditions
Interventions
During 5 days of screening stool collection, stool samples will be collected from study participants and analysed with a texture analyser (TAXT). Then, 120 eligible subjects who produce hard stools (i
Sponsors
Yakult Honsha (Japan)
Yakult Honsha European Research Centre for Microbiology VOF
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 stools (BS1 and 2 stools) with a frequency of 50% or more during 2 weeks of screening data period (between V1 or Call 1, depending on if a washout period is required, and V2) 4. Produces hard stool with log-transformed TAXT median value of >4.5 (ln g) during 5 days of screening stool collection, this after the 2 weeks data collection determined in inclusion criteria 3 5. Is willing and able to collect every stool at home during 5 consecutive days and this 1 time during the screening period and 2 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 an electronic diary on an internet-connected device (smartphone, tablet, laptop,..) during the screening 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, French 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 child-bearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods (e.g., oral contraceptive, 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 (see section 13) within 2 weeks before the start of screening data collection. If the subject takes any of these medications or products, a washout period of 2 weeks is needed (Optional call 1) 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 Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool consistency measured by a texture analyser (TA.XT Express Texture Analyser) before consumption of the investigational product (IP), and 4 and 8 weeks after starting IP consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stool hardness measured using the Bristol Stool Form Scale score evaluated by an expert before consumption of the investigational product (IP), and 4 and 8 weeks after starting IP consumption 2. Stool water content measured by subtracting dried stool weight from raw stool weight before consumption of the investigational product (IP), and 4 and 8 weeks after starting IP consumption | — |
Countries
Belgium
Contacts
Public ContactTakuya Takahashi
Outcome results
None listed