Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154525
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-11-16
Brief Title:
Effectiveness of Bacillus Spore Probiotics in Reducing Constipation Anorexia and Slow Weight Gain in Children
Sponsor:
Anabio RD
Organization:
Anabio RD
Study Overview
Official Title:
Evaluating the Effectiveness of the LiveSpo Preg-Mom and LiveSpo KIDS Spore Probiotics in Supporting the Reduction of Constipation Anorexia and Slow Weight Gain in Children Aged 24-60 Months
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Constipation is rising globally and is a health concern in Asia Prolonged constipation without proper care can lead to complications affecting a childs physical and psychological development causing significant health and socioeconomic impacts Anorexia is also common in children affecting their nutrient absorption weight gain and height development Anorexic children are 25-3 times more likely to suffer from underweight and stunting A number of studies have suggested that probiotics can reduce stool retention time and improve stool consistency making them a natural and safe option for relieving constipation in adults and children Probiotics particularly spore-forming probiotics like Bacillus clausii Bacillus subtilis and Bacillus coagulans have shown promise in improving gut health and combating anorexia constipation and malnutrition With this background the investigators conduct a research project titled Evaluating the effectiveness of the LiveSpo Preg-Mom and LiveSpo KIDS in supporting the reduction of constipation anorexia and slow weight gain in children aged 24-60 months
The study aims to i Evaluate the effectiveness of LiveSpo Preg-Mom and LiveSpo KIDS in reducing constipation anorexia and slow weight gain in children ii Assessing the impact of probiotic supplementation on pro-inflammatoryanti-inflammatory cytokines concentrations in the blood IgA concentrations in stools and changes in the intestinal microbiota composition in the childrens stools
Study Population The sample size for aims is 201 Description of Sites the study is conducted at three communes in Vo Nhai district Thai Nguyen province
Description of Study Intervention 201 eligible children aged 24-60 months with signs of anorexia constipation and meeting nutritional criteria were selected The selected children are randomly assigned to three experiment groups with 67 children per group Blood samples are taken at the start and after 28 days of intervention and fecal samples are collected at the beginning of the study day day 7 and day 28 of intervention to analyze cytokine IgA concentrations and the gut microbiota The intervention products are labeled with three codes corresponding to the three experiment groups For example AA code is used for LiveSpo Preg-Mom BB code for LiveSpo KIDS CC for code for RO water and these codes can be interchanged as needed
Study duration 12 months
The study aims to i Evaluate the effectiveness of LiveSpo Preg-Mom and LiveSpo KIDS in reducing constipation anorexia and slow weight gain in children ii Assessing the impact of probiotic supplementation on pro-inflammatoryanti-inflammatory cytokines concentrations in the blood IgA concentrations in stools and changes in the intestinal microbiota composition in the childrens stools
Study Population The sample size for aims is 201 Description of Sites the study is conducted at three communes in Vo Nhai district Thai Nguyen province
Description of Study Intervention 201 eligible children aged 24-60 months with signs of anorexia constipation and meeting nutritional criteria were selected The selected children are randomly assigned to three experiment groups with 67 children per group Blood samples are taken at the start and after 28 days of intervention and fecal samples are collected at the beginning of the study day day 7 and day 28 of intervention to analyze cytokine IgA concentrations and the gut microbiota The intervention products are labeled with three codes corresponding to the three experiment groups For example AA code is used for LiveSpo Preg-Mom BB code for LiveSpo KIDS CC for code for RO water and these codes can be interchanged as needed
Study duration 12 months
Detailed Description:
Child malnutrition is a pressing public health concern particularly among those under 5 years old affecting physical mental and motor development leading to chronic issues in adulthood and future generations A report by UNICEF WHO and the World Bank March 2020 emphasized the alarming global malnutrition rates with 1440 million children under 5 experiencing malnutrition including stunting 470 million and severe malnutrition 143 million Lower-middle-income countries bear the brunt with two-thirds of stunted and three-quarters of wasted children worldwide In Vietnam 2020 data 195 of children under 5 are stunted 116 underweight and 47 wasted In parallel constipation is a rising health issue in Asia and worldwide affecting children even in developed economies Functional constipation is prevalent in children 12-28 In Vietnam 246 of 3-5-year-olds face constipation peaking at 549 between 36 and 48 months Untreated constipation poses severe physical psychological and socioeconomic complications such as gastrointestinal inflammation anorexia and nutrient malabsorption Anorexia prevalent in children affects their nutrient absorption growth and height Anorexic children have 25-3 times higher risks of underweight malnutrition and stunting Children suffering from malnutrition and digestive disorders face impaired enzyme production nutrient loss and gut dysbiosis causing slow weight gain Malnourished children with lower immunity become more ill-prone exacerbating anorexia and forming a problematic cycle In recent years the role of probiotics in human health and disease has attracted the attention of researchers This may be partly due to the excellent activity of probiotics in preventing and alleviating illness Currently research on probiotics mainly focuses on treating gastrointestinal diseases with some traditional probiotics However a problem arises when adding these microorganisms can hardly survive in extremely harsh environments Therefore spore-forming probiotics have attracted the interest of researchers The viability and stability of these bacteria are significantly better when compared to other probiotics due to their spore-forming ability Among Bacillus species Bacillus clausii Bacillus subtilis and Bacillus coagulans are bacteria that can form spores stable in the acidic environment of gastric juice and therefore pass through the stomach safely and also produce digestive enzymes such as amylase and protease in the intestine B coagulans is the only Bacillus species that can produce lactic acid which reduces the pH bringing the environment to a slightly acidic status This is an excellent environmental condition for beneficial intestinal bacteria to grow and prevent the growth of harmful bacteria At the same time it enhances absorption and improves anorexia and constipation in children Previous studies also have demonstrated that probiotics can significantly reduce stool retention time in the intestines and improve stool consistency Based on the research results above spore probiotics can be considered natural and safe agents to relieve constipation anorexia and slow weight gain in children To substantiate this argument the investigators plan to conduct a clinical trial titled Evaluating the effectiveness of the LiveSpo Preg-Mom and LiveSpo KIDS spore probiotics in supporting the reduction of constipation anorexia and slow weight gain in children aged 24-60 months
The overall aim of this study is to assess the efficacy of two types of probiotics the first one containing 3 billion spores of three bacterial species Bacillus subtilis B clausii and B coagulans spores LiveSpo Preg-Mom per ampoule and the second one having 3 billion spores of two bacterial species per ampoule LiveSpo KIDS including Bacillus subtilis and B clausii in supporting the treatment of children with constipation anorexia and slow weight gain
The first objective is to evaluate the effectiveness of these products in alleviating typical symptoms of constipation anorexia and slow weight gain The secondary aim is measuring changes in typical cytokines in the blood in IgA indices in stool and microbiota composition in stool before and after supplemental usages of with LiveSpo Preg-Mom and LiveSpo KIDS
For this aim the study is designed as a randomized double-blind and controlled clinical trial with 201 participants diagnosed with constipation anorexia and slow weight gain The participants are randomized into 3 groups using permuted block randomization a control group using RO water CC experimental group 1 using LiveSpo Preg-Mom AA and experimental group 2 using LiveSpo KIDS BB Each patient receives 2 ampoules of the assigned probiotic product daily divided into 2 doses daily The study includes clinical assessment of indicators at days 0 7 and 28 such as weight types of stool frequency of daily bowel movements and average eating time per meal
Contents and Methods for sub-clinical detection The study participants are children aged 24 to 60 months who are diagnosed with constipation anorexia and slow weight gain
Hematology and biochemical tests are conducted on days 0 and 28 at MEDLATEC proper noun hospital Vietnam
A real-time PCR assay is conducted on stool samples at days 0 7 and 28 at the Spobiotic Research Center proper noun to detect probiotic spores including B subtilis B clausii and B coagulans to cross-check the appropriate usage of probiotics or placebo in the experimental and control groups respectively
ELISA tests are conducted at days 0 7 and 28 at the Spobiotic Research Center proper noun to determine pro-inflammatory anti-inflammatory cytokine levels in blood samples and IgA levels in stool samples respectively for evaluating changes in immune-related indicators during the supportive treatment
The tests indicating ratios of bacteria Gr and Gr - in stool samples are conducted at days 0 7 and 28 at MEDLATEC proper noun hospital in order to evaluate the change in the balance between the types of bacteria Gr and Gr - bacteria in gut
The 16S V3-V4 metagenome sequencing analysis is carried out at Macrogen Seoul Korea using next-generation sequencing NGS technology on the Illumina MiSeq platform Illumina San Diego CA USA utilizing a 2 250 bp run configuration DNA samples extracted from stool samples of about 10 representative patients from each group on day 0 and day 28 are used for the analysis to identify changes in the microbiome
Data collection and statistical analysis involve the collection of individual medical records and systematizing patient information into a dataset
The tabular analysis is performed on dichotomous variables using the χ2 test or Fishers exact test when the expected value of any cell is below five Continuous variables are compared using the Wilcoxon test t-test or the Mann-Whitney test when data are not normally distributed To determine if there is a statistically significant difference between the three groups an ANOVA test is performed Spearmans correlation analysis assesses the correlations among the variables Statistical and graphical analyses are performed on GraphPad Prism v843 software GraphPad Software CA USA The significance level of all analyses is set at p 005 P-values The efficacy of LiveSpo Preg-Mom and LiveSpo KIDS is evaluated and compared to the control based on the following clinical and sub-clinical criteria obtained from the Experiment and Control groups Primary outcome is i Symptomatic relief of constipation anorexia and slow weight gain Secondary outcomes are ii Regulated levels of pro-inflammatory cytokines such as IL-6 IL-10 IL-17 IL-23 and TNF-alpha in blood samples iii Regulated IgA levels in fecal samples iv Improved diversity and count of beneficial bacterial species compared to harmful bacteria in the gut microbiota
The overall aim of this study is to assess the efficacy of two types of probiotics the first one containing 3 billion spores of three bacterial species Bacillus subtilis B clausii and B coagulans spores LiveSpo Preg-Mom per ampoule and the second one having 3 billion spores of two bacterial species per ampoule LiveSpo KIDS including Bacillus subtilis and B clausii in supporting the treatment of children with constipation anorexia and slow weight gain
The first objective is to evaluate the effectiveness of these products in alleviating typical symptoms of constipation anorexia and slow weight gain The secondary aim is measuring changes in typical cytokines in the blood in IgA indices in stool and microbiota composition in stool before and after supplemental usages of with LiveSpo Preg-Mom and LiveSpo KIDS
For this aim the study is designed as a randomized double-blind and controlled clinical trial with 201 participants diagnosed with constipation anorexia and slow weight gain The participants are randomized into 3 groups using permuted block randomization a control group using RO water CC experimental group 1 using LiveSpo Preg-Mom AA and experimental group 2 using LiveSpo KIDS BB Each patient receives 2 ampoules of the assigned probiotic product daily divided into 2 doses daily The study includes clinical assessment of indicators at days 0 7 and 28 such as weight types of stool frequency of daily bowel movements and average eating time per meal
Contents and Methods for sub-clinical detection The study participants are children aged 24 to 60 months who are diagnosed with constipation anorexia and slow weight gain
Hematology and biochemical tests are conducted on days 0 and 28 at MEDLATEC proper noun hospital Vietnam
A real-time PCR assay is conducted on stool samples at days 0 7 and 28 at the Spobiotic Research Center proper noun to detect probiotic spores including B subtilis B clausii and B coagulans to cross-check the appropriate usage of probiotics or placebo in the experimental and control groups respectively
ELISA tests are conducted at days 0 7 and 28 at the Spobiotic Research Center proper noun to determine pro-inflammatory anti-inflammatory cytokine levels in blood samples and IgA levels in stool samples respectively for evaluating changes in immune-related indicators during the supportive treatment
The tests indicating ratios of bacteria Gr and Gr - in stool samples are conducted at days 0 7 and 28 at MEDLATEC proper noun hospital in order to evaluate the change in the balance between the types of bacteria Gr and Gr - bacteria in gut
The 16S V3-V4 metagenome sequencing analysis is carried out at Macrogen Seoul Korea using next-generation sequencing NGS technology on the Illumina MiSeq platform Illumina San Diego CA USA utilizing a 2 250 bp run configuration DNA samples extracted from stool samples of about 10 representative patients from each group on day 0 and day 28 are used for the analysis to identify changes in the microbiome
Data collection and statistical analysis involve the collection of individual medical records and systematizing patient information into a dataset
The tabular analysis is performed on dichotomous variables using the χ2 test or Fishers exact test when the expected value of any cell is below five Continuous variables are compared using the Wilcoxon test t-test or the Mann-Whitney test when data are not normally distributed To determine if there is a statistically significant difference between the three groups an ANOVA test is performed Spearmans correlation analysis assesses the correlations among the variables Statistical and graphical analyses are performed on GraphPad Prism v843 software GraphPad Software CA USA The significance level of all analyses is set at p 005 P-values The efficacy of LiveSpo Preg-Mom and LiveSpo KIDS is evaluated and compared to the control based on the following clinical and sub-clinical criteria obtained from the Experiment and Control groups Primary outcome is i Symptomatic relief of constipation anorexia and slow weight gain Secondary outcomes are ii Regulated levels of pro-inflammatory cytokines such as IL-6 IL-10 IL-17 IL-23 and TNF-alpha in blood samples iii Regulated IgA levels in fecal samples iv Improved diversity and count of beneficial bacterial species compared to harmful bacteria in the gut microbiota
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