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

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: Not yet recruiting
• Conditions: Performance; Gut Microbiota; Athlete; Probiotic
• Intervention / Treatment: Dietary supplement: Probiotic Lactiplantibacillus plantarum Dad-13

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia Desy Putriningtyas, Dietisien., M.Gizi; Phone Number: +6285640885101; Email: nataliadesyputriningtyas@mail.ugm.ac.id
• 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: Elvi Noviastuti, S.Gz; Phone Number: +62 852-9025-5675; Email: bpplop.provjateng@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal calprotectin concentration	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

• Sponsor: Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Estimated): April 13, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: probiotic; gut microbiota; performance; athlete
• Other Study ID 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