Clinical trial NCT04164394: Effect of I31 Probiotic on Lactose Intolerance
Official title: Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactose Intolerance
Keywords: Probiotic
Diarrhea
Abdominal pain
Flatulence
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2019-11-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation is 2:1 to probiotic and placebo arms
Primary purpose: TREATMENT

Brief summary: This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects attending Hospital Juarez de Mexico with self-reported lactose intolerance, a minimum lactose intolerance symptom score of 6 points, 20ppm during the Lactose Hydrogen Breath Test (LHBT) and providing Informed Consent.

Exclusion Criteria:

* More than 10 ppm before ingestion of lactose in the Lactose Hydrogen Breath Test (LHBT). If such value was observed, the LHBT test was repeated on a 2nd day, and if \>10ppm persisted, patient was excluded.
* BMI below 18 or above 40
* Subjects not accepting to maintain their dietary and physical activity pattern unchanged for the duration of the study
* Subjects with congenital lactase deficiency
* Pregnant or lactating women
* Significant gastrointestinal disease, such as inflammatory bowel disease, coeliac disease, chronic diarrhea or gastroparesis
* History of gastrointestinal surgery in the 6 months prior to inclusion
* History of intestinal perforation
* History of acute gastroenteritis, acute gastroenteritis or hospitalization in the 4 weeks prior to inclusion
* Substance abuse
* Untreated thyroid disorder
* Cancer
* Other severe diseases that in the doctor's opinion could interfere with the study
* Known allergy to any of the components in the treatments

Primary outcomes:
measure: Overall Symptoms Score
timeFrame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Secondary outcomes:
measure: Abdominal Pain subscore
timeFrame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
measure: Vomiting subscore
timeFrame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
measure: Intestinal Sounds subscore
timeFrame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
measure: Flatulence subscore
timeFrame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
measure: Lactose Hydrogen Breath Test (LHBT)
timeFrame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Juarez de Mexico
state: Cdmx
Study officials:
affiliation: Hospital Juarez de Mexico
name: Nuria Perez Lopez, MD
role: STUDY_DIRECTOR
References: