Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474234
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Modulation of Gut Microbiota by Probiotic in Children
Sponsor:
Min-Tze LIONG
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
Modulation of Gut Microbiota by Probiotic in Children
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of healthy children among pre-school children in Malaysia 7 years old
Detailed Description:
Probiotic is live microorganisms that grant health effects to the host if consumed in sufficient amounts Probiotic bacteria which beneficially affect the host by improving the intestinal microbial balance may affect the immune response thus boosting the body system to combat against diseases
One of the most common gastrointestinal disorders in young children is diarrhea In worldwide it was reported by WHO that 52 million of children under five of age die every year due to preventable diseases involving gut health such as diarrhea Up to date diarrhea still remains as global health issues even in developing countries with 1 million of children deaths reported to be attributed to diarrhea In Malaysia reported cases of diarrhea and acute gastroenteritis have been observed to occur throughout the year with rotavirus-associated diarrhea being the most prevalently identified gastrointestinal disorder
Probiotics have a been administered to children for the maintenance of gut health and to combat gastrointestinal disorders In children probiotics are consumed directly or mixed with a variety of fluids and foods Probiotics such as Lactobacillus GG Bifidobacterium lactis alone or in combination with Streptococcus thermophiles and Lactobacillus reuteri Lactobacillus casei and Lactobacillus acidophilus have been shown to reduce gastrointestinal-related symptoms in a strain-dependent and dose-dependent manner In a review involving 15 clinical studies participants who were on probiotics administration were less likely to have gastrointestinal disorders indicating the efficacy of probiotics in children The effect of probiotics Lactobacillus acidophilus Lactobacillus rhamnosus Bifidobacterium longum and Saccharomyces boulardii also showed decreased time of vomiting in the intervention groups as compared with controls during acute rotavirus diarrhoea The rationale for using probiotics in gut disorders is that they act against enteric pathogens by competing for available nutrients and binding sites making the gut contents acid producing a variety of chemicals increasing specific and non-specific immune responses and colonization resistance against a wide range of gut pathogens
Probiotic bacteria which beneficially affect the host by improving the intestinal microbial balance may affect the immune response thus boosting the body system to combat against diseases Probiotics have been studied extensively for their effects in preventing and treating a multitude of conditions including the treatment of lactose intolerance travellers diarrhoea and the prevention and treatment of nosocomial diarrhoea In acute diarrhoea a reduction in the frequency of diarrhoeal symptoms has been reported in adults and children treated with probiotics Among the beneficial microbes Bifidobacterium is one of the best-known probiotic genus in the world and it is widely applied in the dairy industry as a probiotic Evidences from more than 100 scientific publications based on in vitro in vivo and clinical studies and long consumption history support the safety and health benefits of Bifidobacterium strains The ingestion of yogurt fortified with B longum reduced harmful bacteria such as Enterobacteriaceae Streptococcus and C perfringens while at the same time alter the microbiota gut profile of volunteers with a significant increase of beneficial microbes Bifidobacterium and Lactobacillus species Additionally putrefactive substances in the intestinal environment were also reduced in the presence of the probiotic supplement Such findings suggest that Bifidobacterium strains are safe and could be used further to evaluate its effect in modulating gut health of children
Our previous study involving probiotic Bifidobacterium infantis YLGB-1496 in children with respiratory symptoms human ethics approval number JEP-2023-074 shows good compliance without any adverse effects Preliminary clinical assessments have also shown positive feedbacks from parents and guardians Thus the aim of the present study is to evaluate the same objectives as before in healthy children
One of the most common gastrointestinal disorders in young children is diarrhea In worldwide it was reported by WHO that 52 million of children under five of age die every year due to preventable diseases involving gut health such as diarrhea Up to date diarrhea still remains as global health issues even in developing countries with 1 million of children deaths reported to be attributed to diarrhea In Malaysia reported cases of diarrhea and acute gastroenteritis have been observed to occur throughout the year with rotavirus-associated diarrhea being the most prevalently identified gastrointestinal disorder
Probiotics have a been administered to children for the maintenance of gut health and to combat gastrointestinal disorders In children probiotics are consumed directly or mixed with a variety of fluids and foods Probiotics such as Lactobacillus GG Bifidobacterium lactis alone or in combination with Streptococcus thermophiles and Lactobacillus reuteri Lactobacillus casei and Lactobacillus acidophilus have been shown to reduce gastrointestinal-related symptoms in a strain-dependent and dose-dependent manner In a review involving 15 clinical studies participants who were on probiotics administration were less likely to have gastrointestinal disorders indicating the efficacy of probiotics in children The effect of probiotics Lactobacillus acidophilus Lactobacillus rhamnosus Bifidobacterium longum and Saccharomyces boulardii also showed decreased time of vomiting in the intervention groups as compared with controls during acute rotavirus diarrhoea The rationale for using probiotics in gut disorders is that they act against enteric pathogens by competing for available nutrients and binding sites making the gut contents acid producing a variety of chemicals increasing specific and non-specific immune responses and colonization resistance against a wide range of gut pathogens
Probiotic bacteria which beneficially affect the host by improving the intestinal microbial balance may affect the immune response thus boosting the body system to combat against diseases Probiotics have been studied extensively for their effects in preventing and treating a multitude of conditions including the treatment of lactose intolerance travellers diarrhoea and the prevention and treatment of nosocomial diarrhoea In acute diarrhoea a reduction in the frequency of diarrhoeal symptoms has been reported in adults and children treated with probiotics Among the beneficial microbes Bifidobacterium is one of the best-known probiotic genus in the world and it is widely applied in the dairy industry as a probiotic Evidences from more than 100 scientific publications based on in vitro in vivo and clinical studies and long consumption history support the safety and health benefits of Bifidobacterium strains The ingestion of yogurt fortified with B longum reduced harmful bacteria such as Enterobacteriaceae Streptococcus and C perfringens while at the same time alter the microbiota gut profile of volunteers with a significant increase of beneficial microbes Bifidobacterium and Lactobacillus species Additionally putrefactive substances in the intestinal environment were also reduced in the presence of the probiotic supplement Such findings suggest that Bifidobacterium strains are safe and could be used further to evaluate its effect in modulating gut health of children
Our previous study involving probiotic Bifidobacterium infantis YLGB-1496 in children with respiratory symptoms human ethics approval number JEP-2023-074 shows good compliance without any adverse effects Preliminary clinical assessments have also shown positive feedbacks from parents and guardians Thus the aim of the present study is to evaluate the same objectives as before in healthy children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None