Clinical Trial of Lactiplantibacillus Plantarum Dad-13 on Gut Microbiota Profile and Performance in Adolescent Athletes (Dad-13)

March 19, 2026 updated by: Natalia Desy Putriningtyas, Gadjah Mada University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lilly Arsanti Lestari, Dr.
  • Phone Number: +62 877-3849-5045

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50231
        • Balai Pembinaan dan Pelatihan Olahraga Pelajar Provinsi Jawa Tengah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control group
placebo capsule twice/day
Dietary supplement: Probiotic Lactiplantibacillus plantarum 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.
Other Names:
  • Dad-13

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From pre treatment and the end of treatment at 8 weeks
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
pre treatment and end of treatment at 8 weeks
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.
pre treatment and the end of treatment at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fecal calprotectin concentration
Time Frame: pre treatment and the end of treatment at 8 weeks
Protein in white blood cells that acts as an inflammation marker with measurement using ELISA. Fecall samples was used.
pre treatment and the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gadjah Mada University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KE/FK/0230/EC/2026
  • Beasiswa Pendidikan Indonesia (Other Identifier: Center for Higher Education Funding and Assessment, under The Ministry of Higher Education, Science and Technology)
  • FK-KMK (Other Identifier: Gadjah Mada University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie results in a publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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