Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight
Condition: Childhood Obesity; Childhood Overweight
MeSH terms: Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      This study was a randomized, double-blind controlled protocol in children overweight aged
      6-11 years. This study aimed to evaluate the effect of consuming fermented milk products
      containing Lactobacillus casei strain Shirota (LcS), as a probiotic enriched with prebiotic
      fructans from A. salmiana or inulin-like standard commercial prebiotic to improve the gut
      microbiota modulation. After providing detailed information, written informed consent was
      obtained from parents and written and oral assent from participants before the initial test
      day. Children were eligible for inclusion in the trial if they were overweight according to
      the World Health Organization (≥85th body mass index (BMI) percentile for overweight). The
      trial took place in three full-time elementary schools in San Luis Potosí, México, and the
      screening of the prospective participants took place up to 1 week prior to the randomization.
      Children were evaluated over a 6-week intervention period receiving different fermented milk
      products
    

Detailed description: 
      Male and female children between the ages of 6- 10 years old were recruited from three
      schools located in San Luis Potosi, Mexico. According to the World Health Organization,
      children with overweight were requested to participate and were voluntarily recruited.

      After providing detailed information, written informed consent was obtained from parents and
      written and oral assent from participants before the initial test day. The trial investigated
      the effect of daily intake of fermented milk products containing Lactobacillus casei strain
      Shirota (LcS), LcS plus inulin (LcS+inulin), and LcS plus fructans from A. salmiana
      (LcS+fructans) on gut microbiota composition. The trial protocol was conducted according to
      the principles of the Declaration of Helsinki. It was approved by the Ethical Committee on
      Human Experimentation of the State Committee of Health Education and Research of the Health
      Secretary in San Luis Potosi (register number SLP/012-2017).
    

Intervention name(s): Lactobacillus casei strain Shirota; Lactobacillus casei strain Shirota plus inulin; Lactobacillus casei strain Shirota plus fructans from A. salmiana
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic product were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 15 mL of sterile water were added to the probiotic product.; The Syn-inulin products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of inulin (BENEO GmbH) were diluted in 15 mL of sterile water and added to Syn-inulin products.; The Syn-A. salmiana products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of fructans from A. salmiana were diluted in 15 mL of sterile water and added to Syn-A.salmiana products.
Other intervention name(s): L. casei Shirota; LcS; Probiotic product; LcS + inulin; Synbiotic product; Syn-inulin; Lactobacillus casei strain Shirota plus A.salmiana; LcS + fructans; LcS + A. salmiana; Synbiotic product; Syn- A. salmiana
Intervention MeSH terms: Levan
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Microbiota; Probiotic; Fermented milk product; Synbiotic