NCT03749291: MICROBEkids

Motivational Intervention on the Gut Microbiota of Obese Children

Completed NA Last updated 2 December 2024

What this trial tests

NA trial testing Obemat2.0 therapy in Microbial Colonization in 219 participants. Completed in 31 December 2023.

Timeline

1 January 2019

Primary endpoint
31 December 2021

31 December 2023

Quick facts

Lead sponsor	Institut Investigacio Sanitaria Pere Virgili
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	219
Start date	1 January 2019
Primary completion	31 December 2021
Estimated completion	31 December 2023
Sites	3 locations across Spain

Drugs / interventions tested

• Obemat2.0 therapy
• Usual Clinical Practice

Conditions studied

• Microbial Colonization — all drugs for Microbial Colonization →

Sponsor

Institut Investigacio Sanitaria Pere Virgili — full company profile →

Who can join

Adults 8 to 15, any sex, with Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Animal models and studies on small samples of obese adults have shown that gut microbial diversity and certain types of bacteria could predict the efficacy of the dietetic treatment to improve body mass index (BMI) and the components of metabolic syndrome (MetS). Gut microbiota could distinguish the obese with metabolic syndrome patient than that metabolically healthy. Dietetic therapy could induce changes in the microbiota that could lead to improvement of BMI and the components of the MetS. The aim of MICROBEkids is to test whether the motivational intervention a motivational intervention (OBEMAT2.0) (PI15/00970) is more effective than the conventional intervention to increase the gut microbial diversity and, as a consequence, to improve BMI and MetS components. The role of gut microbiota (through modulation of the short chain fatty acids) will be analyzed as cardiovascular risk factor and as predictor of treatment success. These objectives will be achieved through a clustered clinical trial design with an intervention group that will receive a motivational therapy compared to a control group that will receive a conventional intervention, both during 12 months. The study sample are 319 children (n= 167 in the intervention group) that were enrolled in the clinical trial OBEMAT2.0 (PI15/00970), have had a comprehensive clinical assessment before the intervention (ages 8 to 14) and after 12 months (+3) of therapy (ages 9 to 15) and furthermore have participated in a biological samples collection for the investigation on childhood obesity (COLOBEPED, reference C.0004585).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. CD8 T cells drive anorexia, dysbiosis, and blooms of a commensal with immunosuppressive potential after viral infection.
   Labarta-Bajo L, Gramalla-Schmitz A, Gerner RR, Kazane KR, et al · · 2020 · cited 23× · PMID 32958643 · DOI 10.1073/pnas.2003656117
2. Children's gut microbiota predicts the efficacy of obesity treatment.
   Alcázar M, Luque V, Ferré N, Muñoz-Hernando J, et al · · 2026 · PMID 41711285 · DOI 10.1080/19490976.2026.2631824