Obesity, ChildhoodNCT03883191
Effect of a Three Combined Probiotics Supplementation on Weight Loss in Obese/Overweight Children
A study testing L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder in people with Obesity, Childhood, run by China Medical University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Oct 2017to 18 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Over 6 years old under 18 years old.
- Overweight or obese children without potential disease.Overweight or obese children is defined by the "Children's and Adolescent Growth Body Mass Index (BMI) Recommended Values" published by the National Health Agency of the Ministry of Health and Welfare on June 11, 2013.
Who cannot join
- There are major potential diseases, such as congenital heart disease, severe asthma, chronic hepatitis, renal dysfunction, neurodegenerative diseases and major genetic diseases.
- Drugs such as weight loss drugs, hypolipidemic drugs, hypoglycemic agents, blood pressure lowering drugs, oral steroids, and hormone supplements are being used.
- Those who use probiotics or related products for a long time.
- Those who use antibiotics during the test.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Obesity, Childhood
- Being tested
- L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder, Placebo
- Keywords
- Probiotics, Overweight, Obese, Children, Weight reduction
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powderOther
Taking 1 pack of L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder three times a day before meals for three months.
PlaceboOther
Taking 1 pack of placebo powder three times a day before meals for three months.
| Study group | Role | What they receive |
|---|---|---|
| Mix probiotics powder | Experimental | Taking 1 pack of L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder three times a day before meals for three months. Receives: Other: L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder |
| Placebo powder | Placebo comparator | Taking 1 pack of placebo powder three times a day before meals for three months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the body mass index (BMI) after intervention
Body weight (kg) and height (m) will be combined to report BMI in kg/m^2, normal BMI value is defined by the "Children's and Adolescent Growth Body Mass Index Recommended Values" published by the National Health Agency of the Ministry of Health and Welfare on June 11, 2013. Probiotics and placebo group BMI value will be presented as an average, lower values represent a better outcome.
Measured: Up to 3 months.
Change in the waist circumference after intervention
Waist circumference in centimeters, probiotics and placebo group waist circumference value will be presented as an average, lower values represent a better outcome.
Measured: Up to 3 months.
Change in the body fat after intervention
Body fat (%) in percentage of body weight, probiotics and placebo group body fat percentage will be presented as an average, lower values represent a better outcome.
Measured: Up to 3 months.
Change in the blood pressure after intervention
Blood pressure in mmHg, probiotics and placebo group blood pressure value will be presented as an average, lower values represent a better outcome.
Measured: Up to 3 months.
Change in the blood sugar and blood lipids after intervention
Blood sugar and blood lipids in mg/dl, probiotics and placebo group blood sugar and blood lipids value will be presented as an average, lower values represent a better outcome.
Measured: Up to 3 months.
Change in the liver function after intervention
Liver function is defined as glutamic oxaloacetic transaminase (GOT) and glutamic pyruvic transaminase (GPT) in IU/L, probiotics and placebo group GOT and GPT value will be presented as an average, lower values represent a better outcome.
Measured: Up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start24 Oct 2017
- Primary completion24 Feb 2018
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Probiotic or placebo group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, An-Chyi Chen, China Medical University Hospital
- Investigators
- Hung-chih Lin, Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883191
- Sponsor's protocol ID
- CMUH105-REC2-096
- Status last verified
- Oct 2022
- First submitted
- 13 Mar 2019
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Three Combined Probiotics Supplementation on Weight Loss in Obese/Overweight Children
- ClinicalTrials.gov ID
- NCT03883191
- Acronym / sponsor ID
- CMUH105-REC2-096
- Conditions
- Obesity, Childhood
- Keywords
- Probiotics, Overweight, Obese, Children, Weight reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 24 Feb 2018 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Probiotic or placebo group
| Arm | Type | Receives |
|---|---|---|
| Mix probiotics powder | Experimental | Other: L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powderTaking 1 pack of L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder three times a day before meals for three months. |
| Placebo powder | Placebo comparator | Other: PlaceboTaking 1 pack of placebo powder three times a day before meals for three months. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Over 6 years old under 18 years old.
- Overweight or obese children without potential disease.Overweight or obese children is defined by the "Children's and Adolescent Growth Body Mass Index (BMI) Recommended Values" published by the National Health Agency of the Ministry of Health and Welfare on June 11, 2013.
Key exclusion criteria (4 listed)
- There are major potential diseases, such as congenital heart disease, severe asthma, chronic hepatitis, renal dysfunction, neurodegenerative diseases and major genetic diseases.
- Drugs such as weight loss drugs, hypolipidemic drugs, hypoglycemic agents, blood pressure lowering drugs, oral steroids, and hormone supplements are being used.
- Those who use probiotics or related products for a long time.
- Those who use antibiotics during the test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powderTaking 1 pack of L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder three times a day before meals for three months. | Other | Mix probiotics powder |
| PlaceboTaking 1 pack of placebo powder three times a day before meals for three months. | Other | Placebo powder |
Primary outcome
Change in the body mass index (BMI) after intervention
Time frame: Up to 3 months.
Body weight (kg) and height (m) will be combined to report BMI in kg/m^2, normal BMI value is defined by the "Children's and Adolescent Growth Body Mass Index Recommended Values" published by the National Health Agency of the Ministry of Health and Welfare on June 11, 2013. Probiotics and placebo group BMI value will be presented as an average, lower values represent a better outcome.
Change in the waist circumference after intervention
Time frame: Up to 3 months.
Waist circumference in centimeters, probiotics and placebo group waist circumference value will be presented as an average, lower values represent a better outcome.
Change in the body fat after intervention
Time frame: Up to 3 months.
Body fat (%) in percentage of body weight, probiotics and placebo group body fat percentage will be presented as an average, lower values represent a better outcome.
Change in the blood pressure after intervention
Time frame: Up to 3 months.
Blood pressure in mmHg, probiotics and placebo group blood pressure value will be presented as an average, lower values represent a better outcome.
Change in the blood sugar and blood lipids after intervention
Time frame: Up to 3 months.
Blood sugar and blood lipids in mg/dl, probiotics and placebo group blood sugar and blood lipids value will be presented as an average, lower values represent a better outcome.
Change in the liver function after intervention
Time frame: Up to 3 months.
Liver function is defined as glutamic oxaloacetic transaminase (GOT) and glutamic pyruvic transaminase (GPT) in IU/L, probiotics and placebo group GOT and GPT value will be presented as an average, lower values represent a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-chih Lin study director
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder in people with Obesity, Childhood, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the body mass index (BMI) after intervention (time frame: Up to 3 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.