Probiotic Intervention for Occasional Constipation

Gut Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444139
• Other study ID #: 23PICPP01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Probi AB
• Contact: Nisrine Zakaria
• Phone: 12262424559
• Email: nzakaria[@]kgkscience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Gut Function
• Occasional Constipation

Intervention

Dietary Supplement:
• Probiotics
Probiotics
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	KGK Science Clinic	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transit time	Difference in change in gut transit time as assessed by blue-dye method	Baseline to day 56
Secondary	Bowel movements	Frequency of complete and spontaneous bowel movements (CSBM)	Baseline to day 28 and day 56
Secondary	Stool consistency	Evaluated by Bristol stool form scale	Baseline to day 28 and day 56
Secondary	Bloating and flatulence	Frequency	Baseline to day 28 and day 56
Secondary	Quality of life	Evaluated by a questionnaire	Baseline to day 28 and day 56
Secondary	Digestive symptoms	Evaluated by a questionnaire	Baseline to day 28 and 56