Childhood ObesityPhase 4POST-OBNCT04151823
Effect of POSTbiotics Supplementation on Microbiome in OBese Children: the POST-OB Study
A Phase 4 study testing Vitamin D3, Immunofos and Promotion of physical activity in people with Childhood Obesity, run by University of Milan at 1 site in Italy.
Trial summary
This study evaluates the possible effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Vitamin D3, Immunofos and Promotion of physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2019to 7 Jan 2021
- Phase
- Phase 4
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 <Age <14 years
- Severe obesity (>3 DS) according to WHO classification.
- Gestational age: 37-42 weeks.
- Birth-weight: > 2500 g e < 4000 g
- Caucasian
Who cannot join
- secondary obesity
- supplementation with pre/probiotics (in the previous 3 months);
- antibiotic treatment (in the previous 3 months);
- chronic or acute intestinal diseases (in the previous 3 months).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Paolo
Milan, 20142
Elvira Verduci, MD PhD Assistant Professor, +39 0281844508, elvira.verduci@unimi.it
About this study
This study evaluates the possible effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. It also wants to determine whether postbiotics supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co-morbidities.
All participants will follow a behaviour (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity.
Postbiotics and vitamin D3 will be given orally for four months; patients will be evaluated four months after supplementation and diet-lifestyle intervention and four months after the end of supplementation and after the alone diet-lifestyle intervention with blood testing and echosonography of the liver.
Read the detailed description
25-30 Caucasian obese children will be enrolled at the Pediatric Department of San Paolo Hospital - University of Milan.
Stool samples from all enrolled patients at the different time points (t0, before supplementation and diet-lifestyle intervention, t1, four months after supplementation and diet-lifestyle intervention and t2 four months after the end of supplementation and after the alone diet-lifestyle intervention) will be collected and stored at -80°C until the following investigation:
- study of the microbiota biodiversity by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children;
- analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) in order to monitor the effect of postbiotics intake modulating microbial metabolite production.
The following tasks will be also performed at t0, t1 and t2:
- Clinical examination including: physical examination, Tanner score evaluation; Bristol Stool Chart
- Blood pressure will be checked in all children by using oscillometric devices validated in the pediatric age group.
- Anthropometry including body circumferences and skinfolds, calculation of BMI z scores and body composition. Body composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA).
- Dietary assessment:
- Food intakes will be recorded by prospective 3-d weighed food records obtained with food scales. Parents will be advised on how to record all food and beverages consumed during 2 weekdays and 1 weekend day. Quantification and analysis of the energy intake and nutrient composition will be performed with an ad hoc PC software (MètaDieta®, Me.Te.Da S.r.l., San Benedetto del Tronto, Italy).
- Mediterranean Diet Quality Index (KIDMED) questionnaire for Mediterranean Diet assessment. The KIDMED index ranges from 0 to 12, and is based on a 16-question test that can be self-administered. The sums of the values from the administered test will be classified into three levels:
- 8 or more: optimal Mediterranean diet;
- 4-7: improvement needed to adjust intake to Mediterranean patterns.
- 3 or less: very low diet quality.
- Hematological and biochemical status including:
- Complete cell blood count;
- Metabolic and nutritional parameters according to local routines for childhood obesity (fasting glucose, fasting insulin, LDL, HDL, total cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B levels, transaminases and amma-glutamyl transferase). Oral Glucose Tolerance Test (OGTT) will be performed. The insulin sensitivity and insulin resistance was assessed by calculating HOMA index (Homeostasis Model Assessment) and QUICKI (Quantitative Insulin-Sensitivity Check Index), using the following formulas:
- HOMA: fasting plasma insulin in mU/l x FPG in mmol/l/22.5
- QUICKI: 1/(log10 fasting plasma insulin in mU/l + log10 glucose in mg/dl)
- Inflammatory index (VES, high-sensitive CRP, including fecal calprotectin)
- Liver ultrasonography will be performed by a single evaluator.
All participants will follow a behavior (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity.
Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; fermented fructooligosaccharides from Lactobacillus paracasei strain CNCM I-5220). 2 mk of product will give 1600 UI/die of VIT D3.
- Conditions
- Childhood Obesity
- Being tested
- Vitamin D3, Immunofos, Promotion of physical activity, Healthy food habits promotion
- Keywords
- Childhood obesity, Nutrition, Gut microbiota, Postbiotics
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN: 2 mL of product will give 1600 UI/die of VIT D3.
ImmunofosDrug
Postbiotics will be given at the dose of 80 mg/day. immunofos from Lactobacillus paracasei CNCM I-5220).
Promotion of physical activityOther
Promotion of physical activity will be encouraged at t0, t1, t2
Healthy food habits promotionOther
Promotion of healthy food habits will be encouraged at t0, t1, t2
| Study group | Role | What they receive |
|---|---|---|
| Postbiotic &vitamin D3, lifestyle intervention. | Experimental | Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; immunofos from Lactobacillus paracasei CNCM I-5220). 2 mL of product will give 1600 UI/die of VIT D3. Healthy living habits will be encouraged at t0, t1 and t2 visit. Receives: Drug: Vitamin D3; Drug: Immunofos; Other: Promotion of physical activity; Other: Healthy food habits promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota composition
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in short chain fatty acids production by gut microbiota
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Secondary outcomes (26)
Changes in HDL-cholesterol levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in LDL-cholesterol levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in triglycerides levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in systemic arterial blood pressure
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in body mass index
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in Bristol stool chart
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in puberal stage
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in fasting glucose levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in fasting insulin levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in oral glucose tolerance test results
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in Apoprotein A1 levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in Apoprotein B levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in alanine aminotransferase (ALT) levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in aspartate aminotransferase (AST) levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in Gamma-glutamyl transferase (GGT) levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in complete cell blood count
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in total cholesterol levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in Homeostasis Model Assessment (HOMA) index
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in Quantitative Insulin-Sensitivity Check Index (QUICKI)
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in erythrocyte sedimentation rate (ESR)
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in C-reactive protein (CRP) levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in fecal calprotectin levels
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Echosonographic changes in liver morphology (degree of steatosis)
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in body mass composition assessed with air displacement plethysmography system
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in body circumference (waist, left arm)
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in body skinfold thickness (waist, posterior skinfold and anterior skinfold of left arm)
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start7 Jan 2019
- Primary completion7 Jan 2021 (estimated)
- Study completion7 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvira Verduci, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151823
- Sponsor's protocol ID
- 2015/ST/135-2
- Acronym
- POST-OB
- Status last verified
- Jul 2020
- First submitted
- 30 Oct 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of POSTbiotics Supplementation on Microbiome in OBese Children: the POST-OB Study
- ClinicalTrials.gov ID
- NCT04151823
- Acronym / sponsor ID
- POST-OB / 2015/ST/135-2
- Conditions
- Childhood Obesity
- Keywords
- Childhood obesity, Nutrition, Gut microbiota, Postbiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 7 Jan 2021 (estimated)
- Study completion
- 7 Jan 2021 (estimated)
- First posted
- 5 Nov 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 study evaluates the possible effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. It also wants to determine whether postbiotics supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co-morbidities.
All participants will follow a behaviour (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity.
Postbiotics and vitamin D3 will be given orally for four months; patients will be evaluated four months after supplementation and diet-lifestyle intervention and four months after the end of supplementation and after the alone diet-lifestyle intervention with blood testing and echosonography of the liver.
Detailed description
25-30 Caucasian obese children will be enrolled at the Pediatric Department of San Paolo Hospital - University of Milan.
Stool samples from all enrolled patients at the different time points (t0, before supplementation and diet-lifestyle intervention, t1, four months after supplementation and diet-lifestyle intervention and t2 four months after the end of supplementation and after the alone diet-lifestyle intervention) will be collected and stored at -80°C until the following investigation:
- study of the microbiota biodiversity by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children;
- analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) in order to monitor the effect of postbiotics intake modulating microbial metabolite production.
The following tasks will be also performed at t0, t1 and t2:
- Clinical examination including: physical examination, Tanner score evaluation; Bristol Stool Chart
- Blood pressure will be checked in all children by using oscillometric devices validated in the pediatric age group.
- Anthropometry including body circumferences and skinfolds, calculation of BMI z scores and body composition. Body composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA).
- Dietary assessment:
- Food intakes will be recorded by prospective 3-d weighed food records obtained with food scales. Parents will be advised on how to record all food and beverages consumed during 2 weekdays and 1 weekend day. Quantification and analysis of the energy intake and nutrient composition will be performed with an ad hoc PC software (MètaDieta®, Me.Te.Da S.r.l., San Benedetto del Tronto, Italy).
- Mediterranean Diet Quality Index (KIDMED) questionnaire for Mediterranean Diet assessment. The KIDMED index ranges from 0 to 12, and is based on a 16-question test that can be self-administered. The sums of the values from the administered test will be classified into three levels:
- 8 or more: optimal Mediterranean diet;
- 4-7: improvement needed to adjust intake to Mediterranean patterns.
- 3 or less: very low diet quality.
- Hematological and biochemical status including:
- Complete cell blood count;
- Metabolic and nutritional parameters according to local routines for childhood obesity (fasting glucose, fasting insulin, LDL, HDL, total cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B levels, transaminases and amma-glutamyl transferase). Oral Glucose Tolerance Test (OGTT) will be performed. The insulin sensitivity and insulin resistance was assessed by calculating HOMA index (Homeostasis Model Assessment) and QUICKI (Quantitative Insulin-Sensitivity Check Index), using the following formulas:
- HOMA: fasting plasma insulin in mU/l x FPG in mmol/l/22.5
- QUICKI: 1/(log10 fasting plasma insulin in mU/l + log10 glucose in mg/dl)
- Inflammatory index (VES, high-sensitive CRP, including fecal calprotectin)
- Liver ultrasonography will be performed by a single evaluator.
All participants will follow a behavior (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity.
Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; fermented fructooligosaccharides from Lactobacillus paracasei strain CNCM I-5220). 2 mk of product will give 1600 UI/die of VIT D3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postbiotic &vitamin D3, lifestyle intervention. | Experimental | Drug: Vitamin D3, Drug: Immunofos, Other: Promotion of physical activity, Other: Healthy food habits promotionPostbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; immunofos from Lactobacillus paracasei CNCM I-5220). 2 mL of product will give 1600 UI/die of VIT D3. Healthy living habits will be encouraged at t0, t1 and t2 visit. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 6 <Age <14 years
- Severe obesity (>3 DS) according to WHO classification.
- Gestational age: 37-42 weeks.
- Birth-weight: > 2500 g e < 4000 g
- Caucasian
Key exclusion criteria (4 listed)
- secondary obesity
- supplementation with pre/probiotics (in the previous 3 months);
- antibiotic treatment (in the previous 3 months);
- chronic or acute intestinal diseases (in the previous 3 months).
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 |
|---|---|---|
| Vitamin D32 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN: 2 mL of product will give 1600 UI/die of VIT D3. | Drug | Postbiotic &vitamin D3, lifestyle intervention. |
| ImmunofosPostbiotics will be given at the dose of 80 mg/day. immunofos from Lactobacillus paracasei CNCM I-5220). | Drug | Postbiotic &vitamin D3, lifestyle intervention. |
| Promotion of physical activityPromotion of physical activity will be encouraged at t0, t1, t2 | Other | Postbiotic &vitamin D3, lifestyle intervention. |
| Healthy food habits promotionPromotion of healthy food habits will be encouraged at t0, t1, t2 | Other | Postbiotic &vitamin D3, lifestyle intervention. |
Primary outcome
Changes in gut microbiota composition
Time frame: t0: 0 t1: +4 months t2: +8 months
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Changes in short chain fatty acids production by gut microbiota
Time frame: t0: 0 t1: +4 months t2: +8 months
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
26 secondary outcomes
Changes in HDL-cholesterol levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in LDL-cholesterol levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in triglycerides levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in systemic arterial blood pressure
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body mass index
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in Bristol stool chart
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in puberal stage
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fasting glucose levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fasting insulin levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in oral glucose tolerance test results
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in Apoprotein A1 levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in Apoprotein B levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in alanine aminotransferase (ALT) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in aspartate aminotransferase (AST) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in Gamma-glutamyl transferase (GGT) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in complete cell blood count
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in total cholesterol levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in Homeostasis Model Assessment (HOMA) index
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in Quantitative Insulin-Sensitivity Check Index (QUICKI)
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in erythrocyte sedimentation rate (ESR)
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in C-reactive protein (CRP) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fecal calprotectin levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Echosonographic changes in liver morphology (degree of steatosis)
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body mass composition assessed with air displacement plethysmography system
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body circumference (waist, left arm)
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body skinfold thickness (waist, posterior skinfold and anterior skinfold of left arm)
Time frame: t0: 0 t1: +4 months t2: +8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3, Immunofos and Promotion of physical activity in people with Childhood Obesity, run by University of Milan at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Jul 2020. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elvira Verduci, PhD (3934771218, elvira.verduci@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota composition (time frame: t0: 0 t1: +4 months t2: +8 months). The study lists 2 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 28 Jul 2020.