An interventional study of Placebo and I31 Probiotic in Lactose Intolerance, sponsored by Hospital Juarez de Mexico. Completed at 1 site in Mexico. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Hospital Juarez de Mexico · Not applicable, Interventional, and Treatment
This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.
People with lactose intolerance are unable to fully digest the sugar (lactose) in milk. As a result, they may have diarrhea, abdominal pain, gas and bloating after eating or drinking dairy products. A deficiency of lactase - an enzyme produced in your small intestine - is usually responsible for lactose intolerance. Many people have low levels of lactase but are able to digest milk products without problems. In lactose intolerance, though, lactase deficiency leads to symptoms after eating dairy foods.
I31 is a probiotic formula composed of Pediococcus acidilactici strain CECT7483 and Lactobacillus plantarum strains CECT7484 and CECT7485, previously shown to improve intestinal sensitivity in patients with Irritable Bowel Syndrome (IBS). IBS is a functional intestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits, often accompanied by bloating. Given the overlap in symptoms between IBS and lactose intolerance, it is hypothesized that I31 formula could be beneficial for individuals with lactose intolerance.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 48 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Hospital Juarez de Mexico is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo treatment (maltodextrin), once daily (u.i.d)
Other: Placebo
I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
Dietary Supplement: I31 Probiotic
Placebo treatment (maltodextrin), once daily (u.i.d)
I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
Overall Symptoms Score
Total score of the "Symptoms Questionnaire for Lactose Malabsorption Screening" (Casellas et al. Dig Dis Sci 2009; 54:1059-65). Score ranges 0 to 50, where 50 represents maximum symptoms severity
Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Abdominal Pain subscore
Abdominal pain Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum pain severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)
Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Vomiting subscore
Vomiting Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum vomiting severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)
Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Intestinal Sounds subscore
Intestinal Visual Analog Scale (VAS) sounds subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum intestinal sounds severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)
Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Flatulence subscore
Flatulence Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum flatulence severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)
Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Lactose Hydrogen Breath Test (LHBT)
LHBT test performed with 25 gr of lactose after an overnight fast. Measurements 10 minutes before lactose ingestion and 60, 120 and 180 minutes after lactose ingestion. CO2 (Carbon Dioxide) used as control. If more than 10ppm in the measurement before ingestion of lactose, and LHBT test was rescheduled and recommendations to avoid complex carbohydrates 24h before the test were repeated. Carbon dioxide (CO2) was measured and used to adjust breath sample for non-alveolar dilution of exhaled air.
Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Hospital Juarez de Mexico