Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03883191 |
Other study ID # |
CMUH105-REC2-096 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 24, 2017 |
Est. completion date |
April 18, 2022 |
Study information
Verified date |
October 2022 |
Source |
China Medical University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This program is a double-blind, randomized, placebo-controlled study. Investigators expect to
enroll 100 overweight or obese children those ages 6 to 18 years. A product that containing
three probiotics will be prescribed for study group for 12 weeks plus diet and exercise
guidance, while the control group will be given a placebo plus diet and exercise guidance.
Description:
The prevalence of obesity in adults was up to 40% in Taiwan. The prevalence of overweight and
obesity in Taiwanese boy was over 30%, while close to 30% of Taiwanese girls were overweight
and obesity. Obese children are more prone to becoming obese adults and consequently
increased risk of many complications, including metabolic syndrome, nonalcoholic fatty liver
disease, cardiovascular disease, etc. Therefore, childhood obesity may result in significant
public health burden in the future if it was improperly handled. Unfortunately, there is
still lack of effective way to reduce weight and long-term weight control except for
lifestyle modification.
Recent studies have shown that microflora of the gut are associated with obesity, perhaps one
of the cause of obesity. Many studies have shown that the gut microbiota is different between
obese individuals and normal-weight individuals. The most significant one is that obese
individuals have larger Firmicutes/Bacteroidetes ratio. In the other hand, many studies have
confirmed that probiotic was effectively in weight loss in obese adults. However, there are
only few research in pediatric population in this issue. Researchers have demonstrated that
products containing probiotics are effective in reducing weight, BMI, and serum lipid level
in obese child.
This program is a double-blind, randomized, placebo-controlled study. Investigators expect to
enroll 100 overweight or obese children those ages 6 to 18 years. A product that containing
three probiotics will be prescribed for study group for 12 weeks plus diet and exercise
guidance, while the control group will be given a placebo plus diet and exercise guidance.
Every subjects will receive several tests and examinations before and after the study, such
as: height, weight, BMI, waist circumference, body fat, blood pressure, blood sugar, blood
lipids profile, liver and kidney function, and abdominal ultrasound. Investigators will
compare these parameters between these two groups after the study. Investigators expect to
follow these subjects for more than one year, to see if this product has persistent effects.