Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients

Launched by PROBISEARCH SL · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a probiotic supplement on the gut health of young children aged 3 to 7 who have neurodevelopmental disorders, such as autism spectrum disorder (ASD). Researchers believe that children with these conditions often have changes in their gut bacteria that may be linked to symptoms like stomach pain or constipation. The study will last about six months, during which some children will receive the probiotic, while others will receive a placebo (a substance without any active ingredients) without knowing which one they are getting.

To participate, children must be diagnosed with ASD and show gastrointestinal symptoms like bloating or abnormal stools. Parents or legal guardians must give their consent for their child's participation. Participants will be randomly assigned to either the group receiving the probiotic or the placebo group. This trial aims to see if the probiotic can help improve gut health and possibly alleviate some of the gastrointestinal issues these children face. It’s important to note that children who have recently taken antibiotics, probiotics, or have certain medical conditions may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 3 to 7 years old.
• • Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification.
• • Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).
• • Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.
• Exclusion Criteria:
• • With intake of antibiotics in the last month.
• • With intake of probiotics in the last two weeks.
• • Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.
• • Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).
• • Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.
• • Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
• • Congenital or acquired immunodeficiency.
• • Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).
• • Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol.
• • With oral hyper sensitivity impairments that prevent the uptake of the study product.