Probiotic Intervention for Occasional Constipation

Not Applicable

Not yet recruiting

• Conditions: Gut Function; Occasional Constipation
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT06444139
• Lead Sponsor: Probi AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Posted: 2024-06-05
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Transit time	Baseline to day 56	Difference in change in gut transit time as assessed by blue-dye method

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

KGK Science Clinic; 🇨🇦 London, Ontario, Canada