Gut Function, Occasional Constipation
Conditions
Keywords
Bowel movements, Gut function, Probiotics
Brief summary
The goal of this clinical trial is to study the effect of probiotics on gut function in subjects with occasional constipation. The main question it aim to answer is if intake of probiotics will decrease the transit time. Participants will randomized to either consume probiotics or a placebo product.
Interventions
DIETARY_SUPPLEMENTProbiotics
Probiotics
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females aged 18 - 65 years * With occasional constipation * Agrees to maintain current lifestyle habits * Healthy * Provided voluntary, written, informed consent to participate in the study
Exclusion criteria
* Individuals who are pregnant, breast feeding, or planning to become pregnant during the study * Allergy, sensitivity, or intolerance to study products or clinical assessment materials * Chronic constipation * Current or history of significant diseases or abnormalities of the gastrointestinal tract (examples (include but are not limited to atrophic gastritis, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease) * Unstable metabolic disease or chronic diseases * Unstable hypertension. * Type I or Type II diabetes, cancer * Significant cardiovascular event in the past 6 months. History of or current diagnosis with kidney and/or liver diseases * Self-reported confirmation of current or pre-existing thyroid condition. * Individuals with an autoimmune disease or are immune compromised * Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis, blood/bleeding disorders * Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transit time | Baseline to day 56 | Difference in change in gut transit time as assessed by blue-dye method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel movements | Baseline to day 28 and day 56 | Frequency of complete and spontaneous bowel movements (CSBM) |
| Stool consistency | Baseline to day 28 and day 56 | Evaluated by Bristol stool form scale |
| Bloating and flatulence | Baseline to day 28 and day 56 | Frequency |
| Quality of life | Baseline to day 28 and day 56 | Evaluated by a questionnaire |
| Digestive symptoms | Baseline to day 28 and 56 | Evaluated by a questionnaire |
Countries
Canada
Outcome results
None listed