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Not yet recruitingNCT07476573Dad-13Updated Mar 23, 2026

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

An interventional study of Probiotic Lactiplantibacillus plantarum Dad-13 in Athlete, Probiotic and Performance, sponsored by Gadjah Mada University. Not yet recruiting at 1 site in Indonesia. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Gadjah Mada University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
12 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Athlete
  • Probiotic
  • Performance
  • Gut Microbiota

Keywords

  • athlete
  • probiotic
  • performance
  • gut microbiota
03

In context

Lead sponsor

Gadjah Mada University is the lead sponsor of 63 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Residing in the BPPLOP dormitory of Central Java Province;
  • Having a normal ;
  • Being an athlete in an endurance sport;
  • Having no growth disorders

Exclusion criteria

Exclusion Criteria:

  • Injury, any health 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Control group

    placebo capsule twice/day

    Dietary Supplement: Probiotic Lactiplantibacillus plantarum Dad-13

Interventions

  • Dietary supplementProbiotic 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.

    Also known as: Dad-13

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From pre treatment and the end of treatment at 8 weeks

  2. 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

    Time frame: pre treatment and end of treatment at 8 weeks

  3. 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.

    Time frame: 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.

    Time frame: pre treatment and the end of treatment at 8 weeks

07

Study locations

1 site
  • Balai Pembinaan dan Pelatihan Olahraga Pelajar Provinsi Jawa Tengah
    Semarang, Central Java 50231, Indonesia
08

References and documents

Individual participant data

Plan to share: Yes — IPD that underlie results in a publication.

Supporting information: Study protocol, Informed consent form

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07476573
Lead sponsor
Gadjah Mada University
Responsible party
Natalia Desy Putriningtyas (PhD student and as a Dietisien, Gadjah Mada University) — Principal investigator
First posted
Mar 17, 2026
Start date
Apr 13, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Mar 23, 2026

Study contacts

Natalia Desy Putriningtyas, Dietisien., M.Gizi
Contact
nataliadesyputriningtyas@mail.ugm.ac.id
+6285640885101
Lilly Arsanti Lestari, Dr.
Contact
+62 877-3849-5045

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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