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

June 14, 2022 updated by: Diana Patricia Portales-Pérez, Universidad Autonoma de San Luis Potosí

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosí, Mexico, 78210
        • Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactobacillus casei (Probiotic)
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
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.
Other Names:
  • L. casei Shirota
  • LcS
  • Probiotic product
Experimental: L. casei strain Shirota plus inulin (Syn-Inulin)
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
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.
Other Names:
  • LcS + inulin
  • Synbiotic product
  • Syn-inulin
Experimental: L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana)
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
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 Names:
  • Synbiotic product
  • Lactobacillus casei strain Shirota plus A.salmiana
  • LcS + fructans
  • LcS + A. salmiana
  • Syn- A. salmiana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut bacteria associated with changes of the intervention group
Time Frame: Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each 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
Time Frame: Comparison of BMI-Z score through study completion, 6 weeks intervention of each group.
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
Time Frame: Comparison of fat percentage through study completion, 6 weeks intervention of each group.
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
Time Frame: Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group.
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
Time Frame: Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group.
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
Time Frame: Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Investigators

  • Principal Investigator: Diana Patricia Portales-Pérez, phD, Universidad Autonoma de San Luis Potosí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2017

Primary Completion (Actual)

October 2, 2017

Study Completion (Actual)

October 9, 2017

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Obesity

Clinical Trials on Lactobacillus casei strain Shirota

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe