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