AthleteDad-13NCT07476573
Clinical Trial of Lactiplantibacillus Plantarum Dad-13 on Gut Microbiota Profile and Performance in Adolescent Athletes
A study testing Probiotic Lactiplantibacillus plantarum Dad-13 in people with Athlete and Probiotic, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The aim of this research is to analyze the effect of a Lactiplantibacillus plantarum Dad-13 supplementation on the gut microbiota profile and performance of adolescent athletes. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Athlete, Probiotic, Performance
- What is being tested?
- Probiotic Lactiplantibacillus plantarum Dad-13
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Apr 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Residing in the BPPLOP dormitory of Central Java Province;
- Having a normal body mass index;
- Being an athlete in an endurance sport;
- Having no growth disorders
Who cannot join
- Injury, any health contraindication or failure to perform exercise procedures;
- Gastrointestinal infections, diseases, disorders;
- Past history of gastrointestinal surgery;
- Failure to follow the study protocol;
- Declared general feeling of being unwell
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natalia Desy Putriningtyas, Dietisien., M.Gizi contact
Lilly Arsanti Lestari, Dr. contact
Indonesia1 site
Balai Pembinaan dan Pelatihan Olahraga Pelajar Provinsi Jawa Tengah
Semarang, Central Java, 50231
Elvi Noviastuti, S.Gz, +62 852-9025-5675, bpplop.provjateng@gmail.com
About this study
The aim of this research is to analyze the effect of a Lactiplantibacillus plantarum Dad-13 supplementation on the gut microbiota profile and performance of adolescent athletes.
Read the detailed description
An athlete's physical performance can be influenced by the balance of gut microbiota in the digestive tract. Research shows that as many as 96% of ultramarathon participants (161 km) experience several digestive symptoms such as belching, nausea, vomiting and stress with a failure to reach 35.6% in completing the race. The diversity of an athlete's gut microbiota is higher than that of a normal person. This study is a true experimental study with a double-blind, pre- and posttest randomized controlled trial with a total of 30 athletes as respondents. There are two treatments: the first group will be given 1 gram of capsule preparation containing the probiotic Lactiplantibacillus plantarum Dad-13 given twice/day and the control group given a placebo capsule twice/day. The probiotic intervention was given at breakfast and dinner for 8 weeks. Measurement of the microbiota profile comes from fecal samples to further measure digestive tract health, SCFA levels, and calprotectin concentrations. Analysis of alpha diversity and beta diversity using Microbiome Analyst software. Physical performance was measured using VO2max using a direct laboratory method, namely the COSMED K5 instrument, before and after the intervention in kg/mL. Food intake was measured using a 24-hour food recall method and physical activity using an activity recall method.
- Conditions
- Athlete, Probiotic, Performance, Gut Microbiota
- Being tested
- Probiotic Lactiplantibacillus plantarum Dad-13
- Keywords
- athlete, probiotic, performance, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Lactiplantibacillus plantarum Dad-13Dietary supplement
Also called Dad-13
Lactiplantibacillus plantarum Dad-13 is an indigenous probiotic strain isolated from the curd produced by spontaneous fermentation of buffalo milk in bamboo containers and originates from Minangkabau, West Sumatra, Indonesia.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | placebo capsule twice/day Receives: Dietary Supplement: Probiotic Lactiplantibacillus plantarum Dad-13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota profile
Gut microbiota profiles were measured from fecal samples, then isolated using 16S rDNA sequencing. Fecal samples were collected in the morning.
Results: alfa and beta diversity
Measured: From pre treatment and the end of treatment at 8 weeks
Short chain fatty acid profile
The total level or amount of short chain fatty acid metabolites produced from the fermentation process in the intestine obtained from feces.
Results: Total amount of SCFA, acetic acid, propionic acid, butyric acid
Measured: pre treatment and end of treatment at 8 weeks
Physical Performance
The physical performance measurement used was VO2max. The VO2max measurement method used a direct laboratory method with COSMED K5 before and after the intervention, with units of kg/mL.
Measured: pre treatment and the end of treatment at 8 weeks
Secondary outcomes (1)
Fecal calprotectin concentration
Protein in white blood cells that acts as an inflammation marker with measurement using ELISA. Fecall samples was used.
Measured: pre treatment and the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start13 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthleteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Desy Putriningtyas, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476573
- Sponsor's protocol ID
- KE/FK/0230/EC/2026
- Other IDs
- Beasiswa Pendidikan Indonesia, FK-KMK
- Acronym
- Dad-13
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Lactiplantibacillus Plantarum Dad-13 on Gut Microbiota Profile and Performance in Adolescent Athletes
- ClinicalTrials.gov ID
- NCT07476573
- Acronym / sponsor ID
- Dad-13 / KE/FK/0230/EC/2026
- Conditions
- Athlete, Probiotic, Performance, Gut Microbiota
- Keywords
- athlete, probiotic, performance, gut microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 17 Mar 2026 (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.
The aim of this research is to analyze the effect of a Lactiplantibacillus plantarum Dad-13 supplementation on the gut microbiota profile and performance of adolescent athletes.
Detailed description
An athlete's physical performance can be influenced by the balance of gut microbiota in the digestive tract. Research shows that as many as 96% of ultramarathon participants (161 km) experience several digestive symptoms such as belching, nausea, vomiting and stress with a failure to reach 35.6% in completing the race. The diversity of an athlete's gut microbiota is higher than that of a normal person. This study is a true experimental study with a double-blind, pre- and posttest randomized controlled trial with a total of 30 athletes as respondents. There are two treatments: the first group will be given 1 gram of capsule preparation containing the probiotic Lactiplantibacillus plantarum Dad-13 given twice/day and the control group given a placebo capsule twice/day. The probiotic intervention was given at breakfast and dinner for 8 weeks. Measurement of the microbiota profile comes from fecal samples to further measure digestive tract health, SCFA levels, and calprotectin concentrations. Analysis of alpha diversity and beta diversity using Microbiome Analyst software. Physical performance was measured using VO2max using a direct laboratory method, namely the COSMED K5 instrument, before and after the intervention in kg/mL. Food intake was measured using a 24-hour food recall method and physical activity using an activity recall method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Dietary Supplement: Probiotic Lactiplantibacillus plantarum Dad-13placebo capsule twice/day |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Residing in the BPPLOP dormitory of Central Java Province;
- Having a normal body mass index;
- Being an athlete in an endurance sport;
- Having no growth disorders
Key exclusion criteria (5 listed)
- Injury, any health contraindication or failure to perform exercise procedures;
- Gastrointestinal infections, diseases, disorders;
- Past history of gastrointestinal surgery;
- Failure to follow the study protocol;
- Declared general feeling of being unwell
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 |
|---|---|---|
| Probiotic Lactiplantibacillus plantarum Dad-13Also: Dad-13Lactiplantibacillus plantarum Dad-13 is an indigenous probiotic strain isolated from the curd produced by spontaneous fermentation of buffalo milk in bamboo containers and originates from Minangkabau, West Sumatra, Indonesia. | Dietary supplement | Control group |
Primary outcome
gut microbiota profile
Time frame: From pre treatment and the end of treatment at 8 weeks
Gut microbiota profiles were measured from fecal samples, then isolated using 16S rDNA sequencing. Fecal samples were collected in the morning. Results: alfa and beta diversity
Short chain fatty acid profile
Time frame: pre treatment and end of treatment at 8 weeks
The total level or amount of short chain fatty acid metabolites produced from the fermentation process in the intestine obtained from feces. Results: Total amount of SCFA, acetic acid, propionic acid, butyric acid
Physical Performance
Time frame: pre treatment and the end of treatment at 8 weeks
The physical performance measurement used was VO2max. The VO2max measurement method used a direct laboratory method with COSMED K5 before and after the intervention, with units of kg/mL.
1 secondary outcome
Fecal calprotectin concentration
Time frame: pre treatment and the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication.
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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.
Natalia Desy Putriningtyas, Dietisien., M.Gizi contact
Lilly Arsanti Lestari, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Lactiplantibacillus plantarum Dad-13 in people with Athlete and Probiotic, 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Mar 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Desy Putriningtyas, Dietisien., M.Gizi (+6285640885101, nataliadesyputriningtyas@mail.ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota profile (time frame: From pre treatment and the end of treatment at 8 weeks). The study lists 3 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 Mar 2026.