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NCT Number: NCT07476573

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balai Pembinaan dan Pelatihan Olahraga Pelajar Provinsi Jawa Tengah

Semarang, Central Java, 50231, Indonesia

Location contact

Elvi Noviastuti, S.Gz

CONTACT

[email protected]

+62 852-9025-5675

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Lactiplantibacillus plantarum Dad-13

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lilly Arsanti Lestari, Dr.

CONTACT

+62 877-3849-5045

Natalia Desy Putriningtyas, Dietisien., M.Gizi

CONTACT

[email protected]

+6285640885101

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Acronym: Dad-13

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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