- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164394
Effect of I31 Probiotic on Lactose Intolerance
Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cdmx
-
Mexico City, Cdmx, Mexico, 07760
- Hospital Juarez de Mexico
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo treatment (maltodextrin), once daily (u.i.d)
|
Placebo treatment (maltodextrin), once daily (u.i.d)
|
Experimental: Probiotic
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)
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Symptoms Score
Time Frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
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
|
3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal Pain subscore
Time Frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
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)
|
3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
Vomiting subscore
Time Frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
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)
|
3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
Intestinal Sounds subscore
Time Frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
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)
|
3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
Flatulence subscore
Time Frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
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)
|
3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
Lactose Hydrogen Breath Test (LHBT)
Time Frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
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.
|
3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nuria Perez Lopez, MD, Hospital Juarez de Mexico
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HJM 0431/18-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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