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

Universidad Autonoma de San Luis Potosí

Status: Completed

Conditions: Childhood Obesity; Childhood Overweight

Treatments: Dietary Supplement: Lactobacillus casei strain Shirota plus inulin; Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmiana; Dietary Supplement: Lactobacillus casei strain Shirota

Study type: Interventional

Funder types: Other

Identifiers

NCT05423015

201708

Details and patient eligibility

About

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

Full 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).

Enrollment: 37 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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37 participants in 3 patient groups

Lactobacillus casei (Probiotic)

Experimental group

Description:

Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product)

Treatment:

Dietary Supplement: Lactobacillus casei strain Shirota

L. casei strain Shirota plus inulin (Syn-Inulin)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lactobacillus casei strain Shirota plus inulin

L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmiana