Probiotic Intervention for Occasional Constipation

NCT ID: NCT06444139

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2024-12-13

Brief Summary

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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

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Conditions

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Gut Function Occasional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Probiotics

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Probiotics

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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KGK Science Clinic

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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23PICPP01

Identifier Type: -

Identifier Source: org_study_id

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