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OpenTrials
Completed

NCT Number: NCT06444139

Probiotic Intervention for 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.

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Key information

Conditions

Gut Function Occasional Constipation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KGK Science Clinic

London, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

Probiotics

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Transit time

    Time frame: Baseline to day 56

    Difference in change in gut transit time as assessed by blue-dye method

Secondary outcomes

  1. Bowel movements

    Time frame: Baseline to day 28 and day 56

    Frequency of complete and spontaneous bowel movements (CSBM)

  2. Stool consistency

    Time frame: Baseline to day 28 and day 56

    Evaluated by Bristol stool form scale

  3. Bloating and flatulence

    Time frame: Baseline to day 28 and day 56

    Frequency

  4. Quality of life

    Time frame: Baseline to day 28 and day 56

    Evaluated by a questionnaire

  5. Digestive symptoms

    Time frame: Baseline to day 28 and 56

    Evaluated by a questionnaire

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2024
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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