Humoral Immune ResponseNCT03924076
Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Elementary School Children
A study testing UHT Milk + Lactobacillus plantarum IS-10506 and UHT Milk in people with Humoral Immune Response, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
This study is aimed to determine effect of paraprobiotic Lactobacillus plantarum IS-10506 on humoral immune response by measuring faecal sIgA and blood IgG, IgM, and IgA Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Humoral Immune Response
- What is being tested?
- UHT Milk + Lactobacillus plantarum IS-10506 and UHT Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Nov 2018to 4 Apr 2019
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children at age of 7-9 years
- have normal body mass index (BMI) i.e. -2 ≤ z-score < +1, slightly overweight z-score < +1.5, and slightly underweight z-score > -3.
Who cannot join
- allergic to milk
- consuming other probiotic product
- he/she do not want to stop consumption \& doing washout for 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Indonesian Elementary School Children: a Double Blind, Randomized, Placebo-controlled Trial
This study is aimed to determine effect of paraprobiotic Lactobacillus plantarum IS-10506 on humoral immune response by measuring faecal sIgA and blood IgG, IgM, and IgA
Read the detailed description
The type of the study is double blind randomize placebo-controlled trial with minimum 72 subjects which divided into 2 groups i.e. 1) placebo group which will receive UHT milk (125 mL) and 2) treatment group which will received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL). The subjects have to consume one pack of milk every day for 90 consecutive days. Before and after intervention (day 30 and day 90), several data will be collected i.e. faecal sIgA, blood IgG, IgM, and IgA. The subjects recruited from elementary school in Yogyakarta District.
- Conditions
- Humoral Immune Response
- Being tested
- UHT Milk + Lactobacillus plantarum IS-10506, UHT Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHT Milk + Lactobacillus plantarum IS-10506Dietary supplement
125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group
UHT MilkDietary supplement
125 ml UHT milk given to placebo group
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL) for 90 days Receives: Dietary Supplement: UHT Milk + Lactobacillus plantarum IS-10506 |
| Placebo Group | Placebo comparator | Received UHT milk (125 mL) for 90 days Receives: Dietary Supplement: UHT Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgG
Measuring IgG (ng/mL) in collected serum
Measured: 90 days
Serum IgA
Measuring IgA (ng/mL) in collected serum
Measured: 90 days
Serum IgM
Measuring IgM (ng/mL) in collected serum
Measured: 90 days
Faecal sIgA
Measuring sIgA (ng/mL) in collected feses
Measured: 90 days
Secondary outcomes (2)
Weight
Measuring weight (kg) change
Measured: 90 days
Height
Measuring height (cm) change
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start14 Nov 2018
- Primary completion4 Jan 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humoral Immune ResponseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.Siti Helmyati, DCN, M.Kes, Gadjah Mada University
- Investigators
- Siti Helmyati, DR., Principal investigator, Gadjah Mada UniversityMohammad Juffrie, Prof.dr., Principal investigator, Gadjah Mada UniversityLily A Lestari, DR., Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924076
- Sponsor's protocol ID
- KE/FK/293/EC/2018
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Indonesian Elementary School Children: a Double Blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03924076
- Acronym / sponsor ID
- KE/FK/293/EC/2018
- Conditions
- Humoral Immune Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 23 Apr 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 is aimed to determine effect of paraprobiotic Lactobacillus plantarum IS-10506 on humoral immune response by measuring faecal sIgA and blood IgG, IgM, and IgA
Detailed description
The type of the study is double blind randomize placebo-controlled trial with minimum 72 subjects which divided into 2 groups i.e. 1) placebo group which will receive UHT milk (125 mL) and 2) treatment group which will received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL). The subjects have to consume one pack of milk every day for 90 consecutive days. Before and after intervention (day 30 and day 90), several data will be collected i.e. faecal sIgA, blood IgG, IgM, and IgA. The subjects recruited from elementary school in Yogyakarta District.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: UHT Milk + Lactobacillus plantarum IS-10506Received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL) for 90 days |
| Placebo Group | Placebo comparator | Dietary Supplement: UHT MilkReceived UHT milk (125 mL) for 90 days |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children at age of 7-9 years
- have normal body mass index (BMI) i.e. -2 ≤ z-score < +1, slightly overweight z-score < +1.5, and slightly underweight z-score > -3.
Key exclusion criteria (3 listed)
- allergic to milk
- consuming other probiotic product
- he/she do not want to stop consumption \& doing washout for 2 weeks.
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 |
|---|---|---|
| UHT Milk + Lactobacillus plantarum IS-10506125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group | Dietary supplement | Treatment Group |
| UHT Milk125 ml UHT milk given to placebo group | Dietary supplement | Placebo Group |
Primary outcome
Serum IgG
Time frame: 90 days
Measuring IgG (ng/mL) in collected serum
Serum IgA
Time frame: 90 days
Measuring IgA (ng/mL) in collected serum
Serum IgM
Time frame: 90 days
Measuring IgM (ng/mL) in collected serum
Faecal sIgA
Time frame: 90 days
Measuring sIgA (ng/mL) in collected feses
2 secondary outcomes
Weight
Time frame: 90 days
Height
Time frame: 90 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 23 Apr 2019.
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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.
Siti Helmyati, DR. principal investigator
Gadjah Mada University
Mohammad Juffrie, Prof.dr. principal investigator
Gadjah Mada University
Lily A Lestari, DR. principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UHT Milk + Lactobacillus plantarum IS-10506 and UHT Milk in people with Humoral Immune Response, run by Gadjah Mada University at 1 site in Indonesia.
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 3 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 23 Apr 2019. 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 Indonesia. 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?
Serum IgG (time frame: 90 days). The study lists 4 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 23 Apr 2019.