NCT06444139
Completed
Not Applicable
A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Probiotics on Gastrointestinal Function in Adults With Occasional Constipation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gut Function
- Sponsor
- Probi AB
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Transit time
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females aged 18 - 65 years
- •With occasional constipation
- •Agrees to maintain current lifestyle habits
- •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
Outcomes
Primary Outcomes
Transit time
Time Frame: Baseline to day 56
Difference in change in gut transit time as assessed by blue-dye method
Secondary Outcomes
- Bowel movements(Baseline to day 28 and day 56)
- Stool consistency(Baseline to day 28 and day 56)
- Bloating and flatulence(Baseline to day 28 and day 56)
- Quality of life(Baseline to day 28 and day 56)
- Digestive symptoms(Baseline to day 28 and 56)
Study Sites (1)
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