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Not yet recruiting NCT07476573

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

No phase Interventional Athlete Probiotic Performance Gut Microbiota

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic Lactiplantibacillus plantarum Dad-13.
Who it may be relevant to
Registry conditions: Athlete, Probiotic, Performance, Gut Microbiota. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • gut microbiota profile [Time frame: 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]
  • Physical Performance [Time frame: pre treatment and the end of treatment at 8 weeks]
Secondary outcome measures (1)
  • Fecal calprotectin concentration [Time frame: pre treatment and the end of treatment at 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Balai Pembinaan dan Pelatihan Olahraga Pelajar Provinsi Jawa Tengah — Semarang

Identifiers

NCT: NCT07476573 · KE/FK/0230/EC/2026 · Beasiswa Pendidikan Indonesia · FK-KMK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗