Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310733
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-26
Brief Title:
The Effects of Probiotics Lactobacillus GG in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders
Sponsor:
Prince of Songkla University
Organization:
Prince of Songkla University
Study Overview
Official Title:
The Effects of Probiotics Lactobacillus GG in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders - A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children While most children do not have organic origins so called functional abdominal pain disorders FAPDs the symptoms can nevertheless be severe enough to impair the patients quality of life growth and development To help rule out organic disorders and diagnose this condition some individuals underwent multiple invasive and costly studies
Generally the diagnosis of FAPDs is based on clinical symptoms and criteria it can be divided into irritable bowel syndrome IBS abdominal migraine functional abdominal pain FAP and functional dyspepsia FD Approximately 14 of children globally between the ages of 4 and 18 experience functional abdominal pain issues8 In Thailand the prevalence of FAPDs among adolescents mean age of 16 years was 53 functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes
The pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis which may happen early in life or throughout Hence several studies specifically in western countries reported the role of probiotics specifically Lactobacillus rhamnosus GG LGG in modulating abdominal symptoms in children with FAPDs
It is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity mode of delivery dietary and environmental factors However the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs the investigators aim to evaluate the effects of probiotics LGG in the treatment of children who suffered from FAPDs
The secondary objectives are to measure daily pain score in children with and without FAPDs to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not
Generally the diagnosis of FAPDs is based on clinical symptoms and criteria it can be divided into irritable bowel syndrome IBS abdominal migraine functional abdominal pain FAP and functional dyspepsia FD Approximately 14 of children globally between the ages of 4 and 18 experience functional abdominal pain issues8 In Thailand the prevalence of FAPDs among adolescents mean age of 16 years was 53 functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes
The pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis which may happen early in life or throughout Hence several studies specifically in western countries reported the role of probiotics specifically Lactobacillus rhamnosus GG LGG in modulating abdominal symptoms in children with FAPDs
It is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity mode of delivery dietary and environmental factors However the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs the investigators aim to evaluate the effects of probiotics LGG in the treatment of children who suffered from FAPDs
The secondary objectives are to measure daily pain score in children with and without FAPDs to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None