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Probiotic Intervention for Occasional Constipation

P

Probi AB

Status

Completed

Conditions

Occasional Constipation
Gut Function

Treatments

Dietary Supplement: Probiotics
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06444139
23PICPP01

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Probiotics
Active Comparator group
Treatment:
Dietary Supplement: Probiotics
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Central trial contact

Nisrine Zakaria

Data sourced from clinicaltrials.gov

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