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Efficacy of a Probiotic Formulation in Adults With Lactose Intolerance and Methanogenic Intestinal Overgrowth

NCT07652827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-06-17

No results posted yet for this study

Summary

Introduction: Lactose intolerance (LI) is characterized by specific gastrointestinal symptoms following the consumption of dairy products and lactose-containing foods, symptoms that may also be experienced by individuals with intestinal methanogenic overgrowth (IMO). However, such clinical manifestations may be modulated by the use of probiotics; the aim of this study was to analyze the preliminary efficacy of a probiotic formulation on gastrointestinal symptoms in adults with LI and IMO. Materials and Methods: A randomized, double-blind, placebo-controlled pilot study was conducted with 22 adults who tested positive on a hydrogen breath test (HBT); they were assigned to intervention or placebo groups based on their diagnosis. Accordingly, they completed a Questionnaire on symptoms of Lactose Intolerance (QSLT) and underwent successive nutritional assessments.

Conditions

  • Lactose Intolerance

Interventions

DIETARY_SUPPLEMENT

Probiotic formulation

The individuals had to take one capsule daily containing the bi-strain probiotic formulation (Lacticaseibacillus rhamnosus L-134 and Limosilactobacillus fermentum L-33) for 12 weeks.

DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

The individuals had to take one capsule daily containing maltodextrin for 12 weeks.

Sponsors & Collaborators

  • Universidad de Concepcion

    lead OTHER

Principal Investigators

  • Cristian A Parra Sepúlveda, MSc · CONTRIBUTOR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2025-01-06
Completion
2025-01-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652827 on ClinicalTrials.gov