Constipation
Conditions
Keywords
constipation, prebiotic, postbiotic, gastrointestinal, dietary supplement
Brief summary
In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.
Interventions
DIETARY_SUPPLEMENTABB i5
Prebiotic ABB i5 (NextDext®, 5g)
DIETARY_SUPPLEMENTABB C24
ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g
Sponsors
Grupo Colisée
AB Biotek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who require hospitalization * Constipation defined as the Rome IV criteria for constipation * Patients with the ability to take the study product orally
Exclusion criteria
* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients. * History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations * Patients last palliative care en stage of end of life or terminal * Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment * Laxatives * Antibiotic treatment in the previous 2 weeks * Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota composition | from baseline to day 14 of supplementation | Changes in microbiota composition through Shanon diversity test and statistical analyses (Continuous variables will be described as mean and standard deviation (SD) or as median and interquartile range; and categorical variables such as absolute frequencies and percentages). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transit time | from baseline to day 14 of supplementation | transit time measured as methane on breathe testing |
| Tolerance and gastro-intestinal comfort | from baseline to day 14 of supplementation | Tolerance and gastro-intestinal comfort (validated questionnaires) life questionnaire: the Digestion-associated Quality of Life Questionnaire (DQLQ) |
| Brain Derived Neurotrophic Factor (BDNF) | from baseline to day 14 of supplementation | levels of Brain Derived Neurotrophic Factor (BDNF) (pg/mL) |
Countries
South Sudan
Outcome results
None listed