NCT07476573

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 12, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

athleteprobioticperformancegut microbiota

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    pre treatment and the end of treatment at 8 weeks

Secondary Outcomes (1)

  • Fecal calprotectin concentration

    pre treatment and the end of treatment at 8 weeks

Study Arms (1)

Control group

EXPERIMENTAL

placebo capsule twice/day

Dietary Supplement: Probiotic Lactiplantibacillus plantarum Dad-13

Interventions

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
Control group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balai Pembinaan dan Pelatihan Olahraga Pelajar Provinsi Jawa Tengah

Semarang, Central Java, 50231, Indonesia

Location

Central Study Contacts

Natalia Desy Putriningtyas, Dietisien., M.Gizi

CONTACT

Lilly Arsanti Lestari, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student and as a Dietisien

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

April 13, 2026

Primary Completion

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, ICF

Locations