CompletedNot Applicable

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

Chile22 participantsStarted 2024-08-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hydrogen breath test (HBT)

Timeframe: From enrollment to the end of treatment at 12 weeks

Trial details

NCT IDNCT07652827

SponsorUniversidad de Concepcion

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-06

View on ClinicalTrials.gov More Lactose Intolerance trials