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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423015
• Other study ID #: 201708
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: October 9, 2017

Study information

• Verified date: June 2022
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 9, 2017
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Childhood Overweight
• Overweight
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
Mexico	Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí	San Luis Potosí

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

Fernandes R, do Rosario VA, Mocellin MC, Kuntz MGF, Trindade EBSM. Effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adult patients with overweight or obesity: A systematic review. Clin Nutr. 2017 Oct;36(5):1197-1206. doi: 10.1016/j.clnu.2016.10.003. Epub 2016 Oct 8. Review. — View Citation

Larsen N, Vogensen FK, Gøbel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4. — View Citation

Martinez-Gutierrez, F., Ratering, S., Juárez-Flores, B., et al. Potential use of Agave salmiana as a prebiotic that stimulates the growth of probiotic bacteria. Lwt, 2017; 84:151-159.

Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27. — View Citation

Nagata S, Chiba Y, Wang C, Yamashiro Y. The effects of the Lactobacillus casei strain on obesity in children: a pilot study. Benef Microbes. 2017 Aug 24;8(4):535-543. doi: 10.3920/BM2016.0170. Epub 2017 Jun 16. — View Citation

Regalado-Rentería E, Aguirre-Rivera JR, Godínez-Hernández CI, García-López JC, Oros-Ovalle AC, Martínez-Gutiérrez F, Martinez-Martinez M, Ratering S, Schnell S, Ruíz-Cabrera MÁ, Juárez-Flores BI. Effects of Agave Fructans, Inulin, and Starch on Metabolic Syndrome Aspects in Healthy Wistar Rats. ACS Omega. 2020 May 6;5(19):10740-10749. doi: 10.1021/acsomega.0c00272. eCollection 2020 May 19. — View Citation

Safavi M, Farajian S, Kelishadi R, Mirlohi M, Hashemipour M. The effects of synbiotic supplementation on some cardio-metabolic risk factors in overweight and obese children: a randomized triple-masked controlled trial. Int J Food Sci Nutr. 2013 Sep;64(6):687-93. doi: 10.3109/09637486.2013.775224. Epub 2013 Mar 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.