CClinicalTrials.gg
Sign In
CompletedNCT06444139Updated Jun 18, 2025

Probiotic Intervention for Occasional Constipation

An interventional study of Probiotics and Placebo in Gut Function and Occasional Constipation, sponsored by Probi AB. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gut Function
  • Occasional Constipation

Browse trials for

Keywords

  • Bowel movements
  • Gut function
  • Probiotics
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Probiotics

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics

    Probiotics

  • Dietary supplementPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. Transit time

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

    Time frame: Baseline to day 56

Secondary outcomes

  1. Bowel movements

    Frequency of complete and spontaneous bowel movements (CSBM)

    Time frame: Baseline to day 28 and day 56

  2. Stool consistency

    Evaluated by Bristol stool form scale

    Time frame: Baseline to day 28 and day 56

  3. Bloating and flatulence

    Frequency

    Time frame: Baseline to day 28 and day 56

  4. Quality of life

    Evaluated by a questionnaire

    Time frame: Baseline to day 28 and day 56

  5. Digestive symptoms

    Evaluated by a questionnaire

    Time frame: Baseline to day 28 and 56

06

Study locations

1 site
  • KGK Science Clinic
    London, Ontario, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06444139
Lead sponsor
Probi AB
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
Jun 25, 2024
Primary completion
Dec 13, 2024
Completion
Dec 13, 2024
Last update
Jun 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Constipation→

Other studies from this sponsor

Probi AB

Start the discussion