gut microbiome
Conditions
Interventions
Powder oral nutritional supplement containing a synbiotic blend of prebiotics and probiotic, a protein blend and a micronutrient blend. The supplement should be dissolved in water prior to administrat
Sponsors
Danone Global research & Innovation center
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male or female subject aged = 60 years. BMI between 18.5-29.9 kg/m2. In good health considering the subject’s age, to the discretion of the investigator. Self-reported regular bowel movements (= 3 days/week and = 3 movements/day). Subject able and willing to adherence to protocol.Subject able to speak, read and understand the local language to communicate with the site staff and to comply with the study instructions.Signed ICF.
Exclusion criteria
Exclusion criteria: Subject that is not in good health, defined as having ongoing metabolic diseases, inflammatory diseases, cancers, asthma or allergy requiring chronic systemic treatment, GI diseases, eating or psychotic disorders, other psychiatric disorders under medication-based treatment, neurological disorders, diagnosed by a physician. Self-reported diarrhea within 2 weeks before screening and enrolment.Any antecedents of digestive surgery, or plan for such a surgery during the study or within 4 weeks after the end of intervention.Subject that plans to have any surgery or intervention requiring a general anaesthesia during the study.Any medical condition or disturbances for which probiotic use is not recommended.Any medical condition or disturbances for which high protein intake is not recommended.Any medical conditions or disturbances that require fibre-free diet. Galactosaemia or known allergies or intolerances of the study product or allergens in the Product and Reference Safety Information (e.g. fish allergy, soy allergy, fibre allergy, cow’s milk protein allergy or lactose intolerance).Medication that affects the GI function or stomach within 8 weeks before screening and enrolment or plan to use of any of these during the study. Non-incidental use or use of > 4 paracetamol tablets [500 mg], NSAIDs, aspirin or antihistamines within the 2 weeks before screening and enrolment or plan for such use in a 2-week period during the study.Other started or stopped medication within the 8 weeks prior to screening and enrolment or plan to start or stop such medication during the study.Use of prebiotic, probiotic or synbiotic supplement or other fibre supplements within the past 2 weeks before screening and enrolment or plan for such use during the study.Subjects with self-reported high daily calcium and vitamin D intake from vitamin supplements (> 500 mg calcium and > 40 µg vitamin D), or plan for high daily doses during the study. Self-reported special diet regime or other special diets or plan for such a diet during the study. Significant change in subject’s dietary and/or physical activity habits within the past 2 weeks or plan for such change during the study. Subject involved in another clinical study with investigational or marketed products affecting the gut microbiota within the past 4 weeks or plans to be involved in such a study during the study. Employees and/or children/family members or relatives of employees of Danone or the participating sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes observed in gut microbiota composition and function from baseline to 1 week of intervention (?V2-V1), from baseline to end of intervention (?V3-V1), from baseline to end of washout period (?V4-V1), and from end of intervention to end of washout period (?V4-V3), assessed with untargeted shotgun sequencing. This includes:Changes in bifidobacteria abundance [percentage] and richness [count]. Changes in presence of probiotic strain DNA in stool samples [yes/no]. Changes in abundance of butyrate-producing bacteria [percentage]Changes in concentration of SCFAs, BCFAs, ammonia and lactate [µmol/L]. Changes in gut microbiota composition. qPCR (optional).Metabolomics (optional).Changes in calprotectin and sIgA from baseline to 1 week of intervention (?V2-V1), from baseline to end of intervention (?V3-V1), from baseline to end of washout period (?V4-V1), from end of intervention to end of washout period (?V4-V3), assessed with immunoassays. Changes in fecal pH from baseline to 1 week of intervention (?V2-V1), from baseline to end of intervention (?V3-V1), from baseline to end of washout period (?V4-V1), and from end of intervention to end of washout period (?V4-V3).Changes in self-reported GI symptoms [score] from baseline to 1 week of intervention (?V2-V1), from baseline to end of intervention (?V3-V1), from baseline to end of washout period (?V4-V1), and from end of intervention to end of washout period (?V4-V3), assessed with GI Tolerance Questionnaire (averaged across the 3 consecutive days of each assessment). Changes in self-reported stool consistency and frequency [score] from baseline to 1 week of intervention (?V2-V1), from baseline to end of intervention (?V3-V1), from baseline to end of washout period (?V4-V1), and from end of intervention to end of washout period (?V4-V3), assessed with BSCF (averaged across the 3 consecutive days of each assessment).Perceived well-being | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability outcome parameters in this study are:Self-reported GI symptoms, assessed with the GI Tolerance Questionnaire, and Self-reported stool consistency and frequency, assessed with the BSCF,after consuming the product for (a) 1 week, (b) 2 weeks, (c) 4 weeks and (d) 4 weeks followed by 2 weeks without consumption. Parameters on safety and tolerance in this study are:Incidence, seriousness, severity and relatedness of (S)AEs.GI tolerance parameters Use of concomitant medication and nutritional or dietary supplements.In case of a serious bacterial infection, blood examination to detect the bacterium and rule out the possibility of an opportunistic infection due to the probiotic strain. | — |
Countries
Netherlands
Contacts
Public ContactE. Mulder
Danone Global research & Innovation center
Outcome results
None listed