Probiotic Intervention for Occasional Constipation

NCT06444139 | Completed

• 1 other identifier: 23PICPP01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Function; Occasional Constipation

Keywords

Bowel movements; Gut function; Probiotics

Outcome Measures

Primary Outcomes (1)

• Transit time

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

  Baseline to day 56

Secondary Outcomes (5)

• Bowel movements

  Baseline to day 28 and day 56

• Stool consistency

  Baseline to day 28 and day 56

• Bloating and flatulence

  Baseline to day 28 and day 56

• Quality of life

  Baseline to day 28 and day 56

• Digestive symptoms

  Baseline to day 28 and 56

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Probiotics

Probiotics

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Probi AB: lead

Study Sites (1)

KGK Science Clinic

London, Ontario, Canada

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: June 25, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: June 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)