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

NCT07652827 | Completed

• 1 other identifier: CEBB Nº 1666-2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotics; Lactose intolerance; Intestinal methanogen overgrowth; Hydrogen breath test; Lactase enzyme

Outcome Measures

Primary Outcomes (1)

• Hydrogen breath test (HBT)

  The HBT was performed orally using lactose as the fermentable substrate (25 g diluted in 125 ml of water). To measure the concentration of H₂ in breath samples (in ppm), breath samples were collected through a mouthpiece connected to the instrument at serial time intervals (Basal - 15 minutes - 15 minutes - 30 minutes - 30 minutes - 30 minutes).

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (1)

• Questionnaire on symptoms of Lactose Intolerance (QSLT)

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Participants who received the capsules containing the two probiotic strains

Dietary Supplement: Probiotic formulation

Placebo

PLACEBO COMPARATOR

Participants who received the capsules without the probiotic strains

Dietary Supplement: Maltodextrin (Placebo)

Interventions

Probiotic formulation DIETARY_SUPPLEMENT

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.

Probiotic

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of legal age (18 years or older)
• Have a confirmed diagnosis of lactose intolerance
• Currently consume dairy products or derivatives, with or without lactose (which is why the participants' diets were not modified)

You may not qualify if:

• Use of probiotics, antibiotics, laxatives, enemas, or prokinetic agents within 1 to 4 weeks prior to the start of the intervention.
• Regular use and/or consumption of lactase enzymes for digestive support within 2 to 4 weeks prior to the start of the intervention.
• Participation in another intervention for the symptomatic management of lactose intolerance.
• Pregnant or breastfeeding women.
• Adults with significant gastrointestinal disease (inflammatory bowel disease, celiac disease, chronic diarrhea, gastroparesis, and gastroenteritis).
• Those who have undergone gastrointestinal surgery within the 6 months prior to the start of the study.
• Individuals with an allergy to any of the excipients included in the probiotic formulation or placebo.
• Individuals with diabetes, whether insulin-dependent or non-insulin-dependent.
• Individuals with cardiac stimulation devices (pacemakers).

Sponsors & Collaborators

• Universidad de Concepcion: lead

Study Sites (1)

Universidad de Concepción

Concepción, 4030000, Chile

Location

Related Publications (26)

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• 10.1080

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• 348813230

  RESULT

• 10.1080/07315724.2021.1891587

  RESULT

• Leis R, de Castro MJ, de Lamas C, Picans R, Couce ML. Effects of Prebiotic and Probiotic Supplementation on Lactase Deficiency and Lactose Intolerance: A Systematic Review of Controlled Trials. Nutrients. 2020 May 20;12(5):1487. doi: 10.3390/nu12051487.

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• Goosenberg E, Afzal M. Lactose Intolerance. 2025 Aug 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532285/

  PMID: 30335318 RESULT

MeSH Terms

Conditions

Lactose Intolerance

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Cristian A Parra Sepúlveda, MSc

  CONTRIBUTOR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent researcher conducted the randomization using a list of participants' names generated in a Microsoft Office Excel® spreadsheet, which he kept in his possession to ensure the anonymity and blinding of the participants throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was a randomized, double-blind, placebo-controlled, quantitative pilot study. For this purpose, non-probabilistic convenience sampling was conducted among adults in Concepción, Chile, during 2024.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: June 17, 2026
• Study Start: August 12, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 31, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)