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Completed NCT07652827

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

Conditions: Lactose Intolerance

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 22
Sponsor: Universidad de Concepcion

Location: Universidad de Concepción Concepción

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.

Eligibility Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07652827). StuddyBuddy aggregates publicly available trial information.