Lactose IntoleranceNCT04164394
Effect of I31 Probiotic on Lactose Intolerance
A study testing I31 Probiotic in people with Lactose Intolerance, run by Hospital Juarez de Mexico at 1 site in Mexico.
Trial summary
This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- I31 Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 13 May 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance
This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.
Read the 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.
- Conditions
- Lactose Intolerance
- Being tested
- Placebo, I31 Probiotic
- Keywords
- Probiotic, Diarrhea, Abdominal pain, Flatulence
- Medical subject headings
- Lactose Intolerance, Diarrhea, Abdominal Pain, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo treatment (maltodextrin), once daily (u.i.d)
I31 ProbioticDietary supplement
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment (maltodextrin), once daily (u.i.d) Receives: Other: Placebo |
| Probiotic | Experimental | 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) Receives: Dietary Supplement: I31 Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start13 May 2019
- Primary completion10 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation is 2:1 to probiotic and placebo arms
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nuria Pérez López, Hospital Juarez de Mexico
- Investigators
- Nuria Perez Lopez, MD, Study director, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164394
- Sponsor's protocol ID
- HJM 0431/18-R
- Status last verified
- Feb 2020
- First submitted
- 11 Nov 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance
- ClinicalTrials.gov ID
- NCT04164394
- Acronym / sponsor ID
- HJM 0431/18-R
- Conditions
- Lactose Intolerance
- Keywords
- Probiotic, Diarrhea, Abdominal pain, Flatulence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- 13 May 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Allocation is 2:1 to probiotic and placebo arms
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo treatment (maltodextrin), once daily (u.i.d) |
| Probiotic | Experimental | Dietary Supplement: I31 ProbioticI31 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) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo treatment (maltodextrin), once daily (u.i.d) | Other | Placebo |
| I31 ProbioticI31 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 | Probiotic |
Primary outcome
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
5 secondary outcomes
Abdominal Pain subscore
Time frame: 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)
Intestinal Sounds subscore
Time frame: 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)
Lactose Hydrogen Breath Test (LHBT)
Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Lactose Intolerance
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Lactose Intolerance and Intestinal Permability
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Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuria Perez Lopez, MD study director
Hospital Juarez de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I31 Probiotic in people with Lactose Intolerance, run by Hospital Juarez de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Symptoms Score (time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.