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Search / Trial NCT02622867

Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers

Launched by INSTITUTO DE INVESTIGACIÓN HOSPITAL UNIVERSITARIO LA PAZ · Dec 2, 2015

Trial Information

Current as of May 30, 2025

Completed

Keywords

Lactobacillus Plantarum Maltodextrin Probiotics Randomized Controlled Trial

ClinConnect Summary

In this randomized double blind controlled trial, a group of healthy middle-aged people (45 to 65 years old) had a nutritional intervention to evaluate the Lactobacillus plantarum 3547 probiotic effects over different inflammation and immune system markers, the experimental group took the experimental supplement (Lactobacillus plantarum 3547) during one period of parallel study (12 weeks), the volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 (10x109 cfu/d) immediately after finishing their meal, the capsule contains: 77 mg probiotic Lp3547 and 390 mg maltodextrins. The ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Men and women from 45 to 65 years old;
  • Body Mass Index (BMI) ≥ 18,5 and \< 40 kg/m2
  • Signed informed consent.
  • Adequate cultural level and understanding for the clinical trial.
  • Free of infections at baseline
  • Exclusion Criteria:
  • Individuals with severe diseases (hepatic, kidney, cancer...);
  • Individuals with diagnosed metabolic syndrome, diabetes and/or hyperthyroidism;
  • Individuals with chronic intestinal pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohn's disease...);
  • Individuals with dementia, mental disease or low cognitive function;
  • Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or immunosuppressants;
  • Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months;
  • Individuals treated with oral antibiotics during two weeks prior to the beginning of the study;
  • Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study;
  • Individuals who intend to quit smoking during the next 20 weeks;
  • Women that consume oral contraceptive;
  • Pregnant women or breastfeeding;
  • Individuals with intensive physical activity (\> 2 hours, more than 3 times per week);
  • Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study;
  • Individuals with regular consumption (\> 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheese...) and/or use of other prebiotics and not to accept suppress their consumption during the study;
  • Individuals with increased alcohol consumption \>30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey , brandy , anise, etc);
  • Individuals with regular use of laxatives (\> 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.

About Instituto De Investigación Hospital Universitario La Paz

Instituto de Investigación Hospital Universitario La Paz is a leading clinical research institution dedicated to advancing medical science and improving patient care through innovative research initiatives. Affiliated with one of Spain's premier hospitals, this institution fosters a collaborative environment that brings together healthcare professionals, researchers, and academics to conduct high-quality clinical trials across various therapeutic areas. With a commitment to ethical standards and patient safety, the institute aims to translate research findings into practical applications that enhance treatment outcomes and contribute to the global medical community.

Locations

Madrid, , Spain

Patients applied

0 patients applied

Trial Officials

Carmen Gómez Candela, MD, PhD

Principal Investigator

La Paz University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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