Obesity, ChildhoodProDPNCT03109587
Pilot Study of Probiotics in Pre-diabetic Adolescents
A study testing Vivomixx in people with Obesity, Childhood, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Vivomixx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 Jul 2020
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female, 13-19 y. of age at Visit 1.
- BMI: 99th percentile or greater
- Acanthosis nigricans
- Pubertal Tanner stage ≥3
Who cannot join
- Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies.
- Known severe immunodeficiency, or immune compromised.
- Current or previous history for insulin or metformin therapy (within last 3 months).
- Antibiotic or probiotic therapy 3 months prior to enrollment.
- Start of new dietary intervention within 1 month prior to enrollment.
- Diagnosed food hypersensitivity or active gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hosptital
Seattle, Washington, 98105
About this study
This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.
Read the detailed description
Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children.
The probiotic strains are known to improve glycemic control.
- Conditions
- Obesity, Childhood
- Being tested
- Vivomixx, Placebo
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivomixxDietary supplement
900 billion of the following probiotic strains: L. acidophilus DSM24735; L. plantarum DSM24730; L. paracasei DSM24733; L. delbrueckii supsp. bulgaricus DSM24734, S. thermophilus DSM24731, B. longum DSM24736, B. breve DSM24732, and B. infantis DSM24737) maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
PlaceboDietary supplement
maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
| Study group | Role | What they receive |
|---|---|---|
| Vivomixx (Visbiome) | Active comparator | 2 packets of probiotics by mouth/day for 12 weeks Receives: Dietary Supplement: Vivomixx |
| Placebo | Placebo comparator | identical in appearance, but without probiotics. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiota composition
Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Change in insulin resistance
Measures of homeostatic model assessment of insulin resistance (HOMA-IR)
Measured: baseline and 12 weeks
Change in inflammation in blood
measures of high sensitive cardio-reactive protein (hsCRP)
Measured: baseline and 12 weeks
Change in inflammation in the gut
measure of fecal calprotectin
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Christian L Roth, MD, Seattle Children's Hospital
- Investigators
- Christian L Roth, MD, Principal investigator, Seattle Children's HospitalChristiane S Hampe, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109587
- Sponsor's protocol ID
- Probiotics/Diabetes Prevention
- Acronym
- ProDP
- Status last verified
- Aug 2020
- First submitted
- 27 Mar 2017
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verma A, Nelson MT, DePaolo WR, Hampe C, Roth CL. A randomized double-blind placebo controlled pilot study of probiotics in adolescents with severe obesity. J Diabetes Metab Disord. 2021 Aug 8;20(2):1289-1300. doi: 10.1007/s40200-021-00855-7. eCollection 2021 Dec.
PubMed 34900780
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Probiotics in Pre-diabetic Adolescents
- ClinicalTrials.gov ID
- NCT03109587
- Acronym / sponsor ID
- ProDP / Probiotics/Diabetes Prevention
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Apr 2017 (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 feasibility and effect of probiotics on glycemic control in obese adolescents.
Detailed description
Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children.
The probiotic strains are known to improve glycemic control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivomixx (Visbiome) | Active comparator | Dietary Supplement: Vivomixx2 packets of probiotics by mouth/day for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placeboidentical in appearance, but without probiotics. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female, 13-19 y. of age at Visit 1.
- BMI: 99th percentile or greater
- Acanthosis nigricans
- Pubertal Tanner stage ≥3
Key exclusion criteria (6 listed)
- Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies.
- Known severe immunodeficiency, or immune compromised.
- Current or previous history for insulin or metformin therapy (within last 3 months).
- Antibiotic or probiotic therapy 3 months prior to enrollment.
- Start of new dietary intervention within 1 month prior to enrollment.
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 |
|---|---|---|
| Vivomixx900 billion of the following probiotic strains: L. acidophilus DSM24735; L. plantarum DSM24730; L. paracasei DSM24733; L. delbrueckii supsp. bulgaricus DSM24734, S. thermophilus DSM24731, B. longum DSM24736, B. breve DSM24732, and B. infantis DSM24737) maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive) | Dietary supplement | Vivomixx (Visbiome) |
| Placebomaltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive) | Dietary supplement | Placebo |
Primary outcome
Change in microbiota composition
Time frame: Baseline and 12 weeks
Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A
3 secondary outcomes
Change in insulin resistance
Time frame: baseline and 12 weeks
Change in inflammation in blood
Time frame: baseline and 12 weeks
Change in inflammation in the gut
Time frame: baseline and 12 weeks
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 Aug 2020.
- Derived from this study: PubMed 34900780Verma A, Nelson MT, DePaolo WR, Hampe C, Roth CL. A randomized double-blind placebo controlled pilot study of probiotics in adolescents with severe obesity. J Diabetes Metab Disord. 2021 Aug 8;20(2):1289-1300. doi: 10.1007/s40200-021-00855-7. eCollection 2021 Dec.
- 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.
Christian L Roth, MD principal investigator
Seattle Children's Hospital
Christiane S Hampe, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivomixx in people with Obesity, Childhood, run by Seattle Children's Hospital at 1 site in United States.
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 4 inclusion and 6 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 Aug 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 United States. 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 microbiota composition (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109587, which also lists 1 linked publication.
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 Aug 2020.