Microbial Colonization Clinical Trial
— MICROBEkidsOfficial title:
Effect of a Motivational Intervention on the Gut Microbiota and the Components of the Metabolic Syndrome in a Population of Obese Children
Verified date | May 2024 |
Source | Institut Investigacio Sanitaria Pere Virgili |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 219 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 15 Years |
Eligibility | Inclusion Criteria: - Age range between 8 and <14 years at enrolment (so that, children would end the treatment at maximum age of 15 years - BMI > 97th percentile of Hernandez references from 1988 (Hernández et al., 1988) as indicated by the Guidelines for Clinical Practice of the Spanish Health System (Grupo de trabajo de la Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la Obesidad Infantojuvenil. Ministerio de Ciencia e Innovación [Spanish Ministry of Sciencee and Innovation], 2009) for the diagnose of the childhood obesity. Exclusion Criteria: - Children with eating disorders - Families not available to attend to scheduled visits - Simultaneous participation in another clinical trial - Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, early puberty or other) - Lack of command of local languages |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Medicine, C/ Sant Llorenç 21 | Reus | Tarragona |
Spain | Iispv- Hospital Sant Joan de Reus | Reus | Tarragona |
Spain | Hospital de Tarragona Joan XXIII | Tarragona |
Lead Sponsor | Collaborator |
---|---|
Institut Investigacio Sanitaria Pere Virgili | Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan de Reus, University Rovira i Virgili |
Spain,
Alcazar M, Escribano J, Ferre N, Closa-Monasterolo R, Selma-Royo M, Feliu A, Castillejo G, Luque V; Obemat2.0 Study Group. Gut microbiota is associated with metabolic health in children with obesity. Clin Nutr. 2022 Aug;41(8):1680-1688. doi: 10.1016/j.cln — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fecal microbial diversity (diversity index like Gini-Simpson) | Effect of the intervention on increments of Fecal microbial diversity | 12 (+3) months | |
Secondary | Fecal Short Chain Fatty Acids: butyrate acid (µg) | Effect of the intervention and microbiota on increments Short Chain Fatty Acids | 12 (+3) months | |
Secondary | Fecal Short Chain Fatty Acids: acetic acid (µg) | Effect of the intervention and microbiota on increments Short Chain Fatty Acids | 12 (+3) months | |
Secondary | Fecal Short Chain Fatty Acids: propionic acid (µg) | Effect of the intervention and microbiota on increments Short Chain Fatty Acids | 12 (+3) months | |
Secondary | Akkermansia Muciniphila (cfu) | Effect of the intervention on increments of Akkermansia Muciniphila in feces | 12 (+3) months |
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