Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight

Study Overview
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Brief Summary
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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
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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).

Official Title
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Elaboration and Assessment of the Effects of Synbiotic on Gut Microbiota Composition of Scholars With Overweight

Conditions
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Childhood Obesity, Childhood Overweight

Intervention / Treatment
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* Dietary Supplement: Lactobacillus casei strain Shirota
* Dietary Supplement: Lactobacillus casei strain Shirota plus inulin
* Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmiana


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children were overweight or obese, according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight, and ≥95th BMI percentile for obesity). Exclusion Criteria: Any known infections, systemic diseases or metabolic diseases, and use of any prescribed medications or antibiotics in the one month before randomization and during the trial.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus casei (Probiotic)<br>Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) | Dietary Supplement: Lactobacillus casei strain Shirota<br>* 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.<br>* Other names: Probiotic product;|
| Experimental: L. casei strain Shirota plus inulin (Syn-Inulin)<br>Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of inulin. | Dietary Supplement: Lactobacillus casei strain Shirota plus inulin<br>* 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.<br>* Other names: Syn-inulin;|
| Experimental: L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana)<br>Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of fructans from A. salmiana. | Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmiana<br>* 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.<br>* Other names: Syn- A. salmiana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut bacteria associated with changes of the intervention group | Comparison of the log2ratio of the genera and the abundance of amplicon sequence variants across the different treatments. | Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each group | 
| Effect of probiotic and synbiotic products intervention on the BMI z-score | Assesment of BMI-Z score changes | Comparison of BMI-Z score through study completion, 6 weeks intervention of each group. | 
| Effect of probiotic and synbiotic products intervention on the fat percentage | Assesment of fat percentage changes | Comparison of fat percentage through study completion, 6 weeks intervention of each group. | 
| Effect of probiotic and synbiotic products intervention on waist and neck circunference | Assesment of waist and neck circunference changes | Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group. | 
| Effect of probiotic and synbiotic products intervention on glucose, triglycerides and cholesterol serum levels | Assesment of glucose, triglycerides and cholesterol serum levels changes | Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of probiotic and synbiotic products intervention on Free Fatty Acid Receptors (FFAR) 2 and 3 levels | Assessment of mRNA levels of FFAR2 and FFAR3 in the peripheral blood mononuclear cells changes | Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Probiotic, Fermented milk product, Synbiotic