Probiotic Intervention for Occasional Constipation

June 13, 2025 updated by: Probi AB

A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Probiotics on Gastrointestinal Function in Adults With Occasional Constipation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • KGK Science Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo
Active Comparator: Probiotics
Dietary supplement: Probiotics
Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transit time
Time Frame: Baseline to day 56
Difference in change in gut transit time as assessed by blue-dye method
Baseline to day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel movements
Time Frame: Baseline to day 28 and day 56
Frequency of complete and spontaneous bowel movements (CSBM)
Baseline to day 28 and day 56
Stool consistency
Time Frame: Baseline to day 28 and day 56
Evaluated by Bristol stool form scale
Baseline to day 28 and day 56
Bloating and flatulence
Time Frame: Baseline to day 28 and day 56
Frequency
Baseline to day 28 and day 56
Quality of life
Time Frame: Baseline to day 28 and day 56
Evaluated by a questionnaire
Baseline to day 28 and day 56
Digestive symptoms
Time Frame: Baseline to day 28 and 56
Evaluated by a questionnaire
Baseline to day 28 and 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Probi AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Actual)

December 13, 2024

Study Completion (Actual)

December 13, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23PICPP01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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