ObesityProb-esityNCT01927107
Effects of Probiotics in Obese Children
A study testing Probiotics mixture in people with Obesity, run by Eskisehir Osmangazi University.
Trial summary
The global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- Probiotics mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Aug 2013
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with obesity according to anthropometric measurements with appropriate weight for age
Who cannot join
- coexistence of secondary obesity, malignancy, immune deficiency, collagen vascular diseases, congenital anomalies, neurological findings, children with receiving concomitant any drugs related chronic condition or antibiotics. Children with exogenous obesity who have also insulin resistance and /or hypertension were also excluded
About this study
Official title: Effects of Probiotics Mixture to Standard Diet Therapy in Obese Children
The global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. The intestinal microbiota has several beneficial functions related to host health and accumulating evidence indicates that the gut microbiota plays a significant role in the development of obesity, obesity-associated inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. Differences in community composition, functional genes and metabolic activities of the gut microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or its complications.
Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on obesity and metabolic syndrome in adults; such experience is limited in children and adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.
Read the detailed description
he global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. The intestinal microbiota has several beneficial functions related to host health and accumulating evidence indicates that the gut microbiota plays a significant role in the development of obesity, obesity-associated inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. Differences in community composition, functional genes and metabolic activities of the gut microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or its complications.
Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on obesity and metabolic syndrome in adults; such experience is limited in children and adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.
- Conditions
- Obesity
- Being tested
- Probiotics mixture
- Keywords
- probiotics, obesity, oxidative stress
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics mixtureDietary supplement
Comparison of probiotic mixture in addition to standard diet therapy vs. standart diet therapy
| Study group | Role | What they receive |
|---|---|---|
| Probiotic mixture | Active comparator | Probiotic mixture including Lactobacillus acidophilus (4.3x108CFU/per sachet), Lactobacillus rhamnosus (4.3x108CFU/ per sachet), Bifidobacterium bifidum (4.3x108CFU/ per sachet), Bifidobacterium longum (4.3x108CFU/ per sachet), Enterococcus faecium (8.2x108CFU/ per sachet, per oral daily for 30 days in addition to standard approach Receives: Dietary Supplement: Probiotics mixture |
| Control | Active comparator | Standard diet therapy Receives: Dietary Supplement: Probiotics mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity related anthropometric measurements
Change of obesity related anthropometric measurements including weight, body mass index, upper arm circumference, tirceps skinfold thickness, waist and hip circumference
Measured: 30th days
Secondary outcomes (2)
Evaluation of biochemical indices and oxidative stress
Serum total cholesterol level, serum triglyceride level, serum LDL-C levels, serum HDL-C levels, serum total anti-oxidant capacity levels, serum total oxidative stress level
Measured: 30th days
Safety
Side effects related with probiotic use: nausea, vomiting, other GIS disturbances, rash
Measured: 30th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startApr 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ener Cagri DINLEYICI, Eskisehir Osmangazi University
- Investigators
- Ener C Dinleyici, MD, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927107
- Sponsor's protocol ID
- Prob-esity
- Acronym
- Prob-esity
- Status last verified
- Jul 2017
- First submitted
- 16 Aug 2013
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics Mixture to Standard Diet Therapy in Obese Children
- ClinicalTrials.gov ID
- NCT01927107
- Acronym / sponsor ID
- Prob-esity / Prob-esity
- Conditions
- Obesity
- Keywords
- probiotics, obesity, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Aug 2013 (estimated)
- 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.
The global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. The intestinal microbiota has several beneficial functions related to host health and accumulating evidence indicates that the gut microbiota plays a significant role in the development of obesity, obesity-associated inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. Differences in community composition, functional genes and metabolic activities of the gut microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or its complications.
Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on obesity and metabolic syndrome in adults; such experience is limited in children and adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.
Detailed description
he global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. The intestinal microbiota has several beneficial functions related to host health and accumulating evidence indicates that the gut microbiota plays a significant role in the development of obesity, obesity-associated inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. Differences in community composition, functional genes and metabolic activities of the gut microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or its complications.
Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on obesity and metabolic syndrome in adults; such experience is limited in children and adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic mixture | Active comparator | Dietary Supplement: Probiotics mixtureProbiotic mixture including Lactobacillus acidophilus (4.3x108CFU/per sachet), Lactobacillus rhamnosus (4.3x108CFU/ per sachet), Bifidobacterium bifidum (4.3x108CFU/ per sachet), Bifidobacterium longum (4.3x108CFU/ per sachet), Enterococcus faecium (8.2x108CFU/ per sachet, per oral daily for 30 days in addition to standard approach |
| Control | Active comparator | Dietary Supplement: Probiotics mixtureStandard diet therapy |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with obesity according to anthropometric measurements with appropriate weight for age
Key exclusion criteria (1 listed)
- coexistence of secondary obesity, malignancy, immune deficiency, collagen vascular diseases, congenital anomalies, neurological findings, children with receiving concomitant any drugs related chronic condition or antibiotics. Children with exogenous obesity who have also insulin resistance and /or hypertension were also excluded
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 |
|---|---|---|
| Probiotics mixtureComparison of probiotic mixture in addition to standard diet therapy vs. standart diet therapy | Dietary supplement | Control, Probiotic mixture |
Primary outcome
Obesity related anthropometric measurements
Time frame: 30th days
Change of obesity related anthropometric measurements including weight, body mass index, upper arm circumference, tirceps skinfold thickness, waist and hip circumference
2 secondary outcomes
Evaluation of biochemical indices and oxidative stress
Time frame: 30th days
Safety
Time frame: 30th days
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 28 Jul 2017.
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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.
Ener C Dinleyici, MD principal investigator
Eskisehir Osmangazi University
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics mixture in people with Obesity, run by Eskisehir Osmangazi University.
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 1 inclusion and 1 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Obesity related anthropometric measurements (time frame: 30th days). 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 28 Jul 2017.