Different kefir formulas for functional constipation in Chilean adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomly assigns 30 adults with functional chronic constipation to one of three groups: homemade whole-milk kefir, homemade skim-milk kefir, or dietary counseling alone. Participants consume their assigned kefir daily (or receive counseling) for a defined period, with weekly product distribution and study assessments. The trial aims to see if kefir formulations improve constipation symptoms and quality of life compared with counseling alone. Eligibility includes adults 18-55 from the Universidad Mayor Huechuraba community who have not used kefir or related products recently. Primary outcomes focus on constipation symptoms and quality of life, with safety and tolerability monitored throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 to 55 years.
* Meet the Rome IV criteria for functional constipation, assessed using the Rome IV Diagnostic Questionnaire, with or without a previous medical diagnosis of chronic functional constipation. When a prior diagnosis is present, it is recorded as medical history, and the Rome IV criteria are verified independently.
* Member of the Universidad Mayor Huechuraba campus community (students, faculty members, administrative staff, or support personnel).
* No consumption of kefir, probiotics, prebiotics, or fermented dairy products during the 4 weeks prior to enrollment.
* Have access to a home refrigerator and be available to attend weekly product distribution sessions and study assessments.

Exclusion Criteria:

* Secondary constipation (organic, pharmacological, or metabolic) or acute constipation.
* Chronic use of corticosteroids, antispasmodics, nonsteroidal anti-inflammatory drugs (NSAIDs), iron supplements, aluminum-containing antacids, opioids, calcium channel blockers, or immunotherapy.
* Current antibiotic treatment or antibiotic use within the 4 weeks prior to enrollment.
* Lactose intolerance, celiac disease, or cow's milk protein allergy.
* Type 1 or Type 2 diabetes mellitus.
* Hypothyroidism.
* Chronic kidney disease.
* Hypoparathyroidism.
* Hypercalcemia.
* Parkinson's disease.
* History of stroke with residual neurological sequelae.
* HIV infection.
* Immunosuppression of any cause.
* Irritable bowel syndrome.
* Inflammatory bowel disease.
* History of bariatric surgery.
* History of colorectal surgery.
* Pregnancy or lactation.

Where it's running

• Universidad Mayor
  Santiago, Huechuraba, Chile Recruiting

Study contacts

• Principal investigator: Cecilia a Sepulveda, Magister En Nutricion — Universidad Mayor
• Study coordinator: Cecilia a Sepulveda, Magister En Nutrición
• Email: CECILIA.SEPULVEDA@UMAYOR.CL
• Phone: +56998921007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.