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Effect of I31 Probiotic on Lactose Intolerance

Primary Purpose

Lactose Intolerance

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Placebo
I31 Probiotic
Sponsored by
Hospital Juarez de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lactose Intolerance focused on measuring Probiotic, Diarrhea, Abdominal pain, Flatulence

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Juarez de Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Probiotic

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
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)
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.

Full Information

First Posted
November 11, 2019
Last Updated
February 7, 2020
Sponsor
Hospital Juarez de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04164394
Brief Title
Effect of I31 Probiotic on Lactose Intolerance
Official Title
Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Juarez de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Intolerance
Keywords
Probiotic, Diarrhea, Abdominal pain, Flatulence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Allocation is 2:1 to probiotic and placebo arms
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment (maltodextrin), once daily (u.i.d)
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo treatment (maltodextrin), once daily (u.i.d)
Intervention Type
Dietary Supplement
Intervention Name(s)
I31 Probiotic
Intervention Description
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)
Primary Outcome Measure Information:
Title
Overall Symptoms Score
Description
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)
Secondary Outcome Measure Information:
Title
Abdominal Pain subscore
Description
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)
Title
Vomiting subscore
Description
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)
Title
Intestinal Sounds subscore
Description
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)
Title
Flatulence subscore
Description
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)
Title
Lactose Hydrogen Breath Test (LHBT)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuria Perez Lopez, MD
Organizational Affiliation
Hospital Juarez de Mexico
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Juarez de Mexico
City
Mexico City
State/Province
Cdmx
ZIP/Postal Code
07760
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of I31 Probiotic on Lactose Intolerance

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