Lactose IntoleranceNCT03952988
Effect of B.Bifidum 900791 Intake in Adult With Hypolactasia and Lactose Intolerance
A study testing Probiotic ice cream in people with Lactose Intolerance, run by University of Chile.
Trial summary
Lactase is high in the newborn intestine, allowing him to digest the high amounts of lactose present in breastmilk. From weaning, lactase is genetically programmed to decrease, reaching residual levels in the adult. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- Probiotic ice cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 31 Jan 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of hypolactasia and lactose intolerance
Who cannot join
- Diarrhea
- Previous gastrointestinal pathologies
- Current or recent intake of antibiotics, anti-inflammatory drugs, laxatives or drugs interfering with intestinal transit
- Alterations of intestinal anatomy or function
- Pregnancy
- Chronic diseases of different etiologies (auto-immune, inflammatory, tumor, etc.).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of the Consumption of a Probiotic (B. Bifidum 900791)-Containing Ice-cream in Adult With Hypolactasia and Lactose Intolerance
Lactase is high in the newborn intestine, allowing him to digest the high amounts of lactose present in breastmilk. From weaning, lactase is genetically programmed to decrease, reaching residual levels in the adult. This situation occurs in 75% of the world population and is known as "adult primary hypolactasia" while the remaining 25% is "lactase persistent" i.e. maintains in adulthood lactase values similar to these of newborns. In subjects with hypolactasia, the intake of milk products can produce digestive symptoms, making that the affected individuals spontaneously reduce the consumption of these products and, therefore, their intake of calcium and proteins.
In addition to lactose-free milk and exogenous lactase, a strategy for the intolerant subjects to continue consuming dairy products is, for example, to consume yogurt, due to the fact that the lactase of the yogurt bacteria continues to function in the intestine of the consumer, hydrolyzing lactose and decreasing the development of digestive symptoms. Similarly, many probiotic strains, such as L. acidophilus NCFM, L. casei CRL431, B. longum 401 and B. bifidum Orla Jensen 1424, express β-galactosidases that hydrolyze lactose, preventing its fermentation and the production of gases. The acute administration of these strains improves lactose tolerance. In addition, a recent study reported that dietary supplementation of intolerant subjects for 4 weeks with L. casei Shirota and B. breve Yakult reduced digestive symptoms and breath hydrogen excretion not only at the end of the period of administration of the probiotics but also 3 months after having discontinued the use of probiotics.
Based on this background, the aim of this study is to determine whether the regular consumption of an ice cream with the strain B. bifidum 900791 improves lactose intolerance in hypolactasic subjects, even after the suspension of the consumption of the product. To determine if this effect is due to the adaptation of the microbiota, the investigators will also evaluate changes in the composition of the microbiota and the generation of volatile fatty acids.
- Conditions
- Lactose Intolerance
- Being tested
- Probiotic ice cream, Placebo ice cream
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ice creamDietary supplement
Also called Bifidice
One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (>10(exp7)/g) every day for 4 weeks
Placebo ice creamDietary supplement
Also called Placebo
One portion (50g) of an ice-cream without probiotic every day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic ice cream |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo ice cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of hydrogen in the HBT
Acute effect of the probiotic on hydrogen excretion after lactose ingestion
Measured: Day 15
Secondary outcomes (20)
Area under curve (AUC) of hydrogen in the HBT
Chronic effect of the probiotic on hydrogen excretion after lactose ingestion
Measured: Day 43
Area under curve (AUC) of hydrogen in the HBT
Remanent effect of the probiotic on hydrogen excretion after lactose ingestion after one month without probiotic ingestion
Measured: Day 71
Fecal microbiota alpha-diversity
Shannon Index
Measured: Days 15
Fecal microbiota alpha-diversity
Shannon Index
Measured: Day 43
Fecal microbiota alpha-diversity
Shannon Index
Measured: Day 71
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Measured: Day 15
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Measured: Day 43
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Measured: Day 71
Fecal counts of B. bifidum 900791
- bifidum 900791 counts in fecal samples
Measured: Days 15
Fecal counts of B. bifidum 900791
- bifidum 900791 counts in fecal samples
Measured: Days 43
Fecal counts of B. bifidum 900791
- bifidum 900791 counts in fecal samples
Measured: Days 71
Fecal beta-galactosidase activity
Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)
Measured: Days 15
Fecal beta-galactosidase activity
Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)
Measured: Days 43
Fecal beta-galactosidase activity
Determination of the microbial beta-galactosidase activity in fecal samples (expressed as U/g)
Measured: Days 71
Fecal short chain fatty acids concentrations
Determination of short chain fatty acids concentrations in fecal samples
Measured: Days 15
Fecal short chain fatty acids concentrations
Determination of short chain fatty acids concentrations in fecal samples
Measured: Days 43
Fecal short chain fatty acids concentrations
Determination of short chain fatty acids concentrations in fecal samples
Measured: Days 71
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Determination of gastrointestinal symptoms (bloating, abdominal distention, abdominal pain, borborygms and flatulence) using a previously validated questionnaire on a scale of 0 (none), 1 (mild), 2 (moderate), 3 (severe). We will define clinically relevant ymptoms as a composite score of 3 or more during the HBT.
Measured: Days 15
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Determination of gastrointestinal symptoms (bloating, abdominal distention, abdominal pain, borborygms and flatulence) using a previously validated questionnaire on a scale of 0 (none), 1 (mild), 2 (moderate), 3 (severe). We will define clinically relevant ymptoms as a composite score of 3 or more during the HBT.
Measured: Days 43
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Determination of gastrointestinal symptoms (bloating, abdominal distention, abdominal pain, borborygms and flatulence) using a previously validated questionnaire on a scale of 0 (none), 1 (mild), 2 (moderate), 3 (severe). We will define clinically relevant ymptoms as a composite score of 3 or more during the HBT.
Measured: Days 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Aug 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At Day 1, hypolactasic subjects will perform a Hydrogen Breath Test (HBT) with a placebo ice-cream with 20g lactose (Negative Control). A second HBT will be carried at Day-8 with the same product + an exogenous lactase (Positive control). A 3° HBT will be carried out at Day 15 with the probiotic ice cream with 20g lactose to determine the acute effect of the probiotic. Posteriorly, the subjects will be randomly assigned in one of 2 groups to consume an ice-cream/d, with or without the probiotic, for 4 weeks. At Day-43, they will carry out a 4° HBT with ice cream with 20g lactose and without probiotic (Evaluation of the chronic effect). At Day 71, after 4 weeks washout period, a 5° HBT will be carried out with the ice cream with lactose and without probiotic, to evaluate the remanence of the effect. A fresh stool will be obtained at days 15, 43 and 71 to determine the presence of the probiotic, microbiota composition, ß-galactosidase activity and short chain fatty acid concentrations.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Gotteland, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952988
- Sponsor's protocol ID
- UChile-Bifidice-2
- Status last verified
- May 2019
- First submitted
- 8 Apr 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marteau P, Pochart P, Flourie B, Pellier P, Santos L, Desjeux JF, Rambaud JC. Effect of chronic ingestion of a fermented dairy product containing Lactobacillus acidophilus and Bifidobacterium bifidum on metabolic activities of the colonic flora in humans. Am J Clin Nutr. 1990 Oct;52(4):685-8. doi: 10.1093/ajcn/52.4.685.
PubMed 2119557Pelletier X, Laure-Boussuge S, Donazzolo Y. Hydrogen excretion upon ingestion of dairy products in lactose-intolerant male subjects: importance of the live flora. Eur J Clin Nutr. 2001 Jun;55(6):509-12. doi: 10.1038/sj.ejcn.1601169.
PubMed 11423928Jiang T, Mustapha A, Savaiano DA. Improvement of lactose digestion in humans by ingestion of unfermented milk containing Bifidobacterium longum. J Dairy Sci. 1996 May;79(5):750-7. doi: 10.3168/jds.S0022-0302(96)76422-6.
PubMed 8792277Almeida CC, Lorena SL, Pavan CR, Akasaka HM, Mesquita MA. Beneficial effects of long-term consumption of a probiotic combination of Lactobacillus casei Shirota and Bifidobacterium breve Yakult may persist after suspension of therapy in lactose-intolerant patients. Nutr Clin Pract. 2012 Apr;27(2):247-51. doi: 10.1177/0884533612440289. Epub 2012 Mar 8.
PubMed 22402407Turroni F, Duranti S, Bottacini F, Guglielmetti S, Van Sinderen D, Ventura M. Bifidobacterium bifidum as an example of a specialized human gut commensal. Front Microbiol. 2014 Aug 21;5:437. doi: 10.3389/fmicb.2014.00437. eCollection 2014.
PubMed 25191315Gargari G, Taverniti V, Balzaretti S, Ferrario C, Gardana C, Simonetti P, Guglielmetti S. Consumption of a Bifidobacterium bifidum Strain for 4 Weeks Modulates Dominant Intestinal Bacterial Taxa and Fecal Butyrate in Healthy Adults. Appl Environ Microbiol. 2016 Sep 16;82(19):5850-9. doi: 10.1128/AEM.01753-16. Print 2016 Oct 1.
PubMed 27451450Hsu CA, Yu RC, Lee SL, Chou CC. Cultural condition affecting the growth and production of beta-galactosidase by Bifidobacterium longum CCRC 15708 in a jar fermenter. Int J Food Microbiol. 2007 May 1;116(1):186-9. doi: 10.1016/j.ijfoodmicro.2006.12.034. Epub 2007 Jan 19.
PubMed 17320993
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of a Probiotic (B. Bifidum 900791)-Containing Ice-cream in Adult With Hypolactasia and Lactose Intolerance
- ClinicalTrials.gov ID
- NCT03952988
- Acronym / sponsor ID
- UChile-Bifidice-2
- Conditions
- Lactose Intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 16 May 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.
Lactase is high in the newborn intestine, allowing him to digest the high amounts of lactose present in breastmilk. From weaning, lactase is genetically programmed to decrease, reaching residual levels in the adult. This situation occurs in 75% of the world population and is known as "adult primary hypolactasia" while the remaining 25% is "lactase persistent" i.e. maintains in adulthood lactase values similar to these of newborns. In subjects with hypolactasia, the intake of milk products can produce digestive symptoms, making that the affected individuals spontaneously reduce the consumption of these products and, therefore, their intake of calcium and proteins.
In addition to lactose-free milk and exogenous lactase, a strategy for the intolerant subjects to continue consuming dairy products is, for example, to consume yogurt, due to the fact that the lactase of the yogurt bacteria continues to function in the intestine of the consumer, hydrolyzing lactose and decreasing the development of digestive symptoms. Similarly, many probiotic strains, such as L. acidophilus NCFM, L. casei CRL431, B. longum 401 and B. bifidum Orla Jensen 1424, express β-galactosidases that hydrolyze lactose, preventing its fermentation and the production of gases. The acute administration of these strains improves lactose tolerance. In addition, a recent study reported that dietary supplementation of intolerant subjects for 4 weeks with L. casei Shirota and B. breve Yakult reduced digestive symptoms and breath hydrogen excretion not only at the end of the period of administration of the probiotics but also 3 months after having discontinued the use of probiotics.
Based on this background, the aim of this study is to determine whether the regular consumption of an ice cream with the strain B. bifidum 900791 improves lactose intolerance in hypolactasic subjects, even after the suspension of the consumption of the product. To determine if this effect is due to the adaptation of the microbiota, the investigators will also evaluate changes in the composition of the microbiota and the generation of volatile fatty acids.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- At Day 1, hypolactasic subjects will perform a Hydrogen Breath Test (HBT) with a placebo ice-cream with 20g lactose (Negative Control). A second HBT will be carried at Day-8 with the same product + an exogenous lactase (Positive control). A 3° HBT will be carried out at Day 15 with the probiotic ice cream with 20g lactose to determine the acute effect of the probiotic. Posteriorly, the subjects will be randomly assigned in one of 2 groups to consume an ice-cream/d, with or without the probiotic, for 4 weeks. At Day-43, they will carry out a 4° HBT with ice cream with 20g lactose and without probiotic (Evaluation of the chronic effect). At Day 71, after 4 weeks washout period, a 5° HBT will be carried out with the ice cream with lactose and without probiotic, to evaluate the remanence of the effect. A fresh stool will be obtained at days 15, 43 and 71 to determine the presence of the probiotic, microbiota composition, ß-galactosidase activity and short chain fatty acid concentrations.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic ice cream |
| Placebo | Placebo comparator | Dietary Supplement: Placebo ice cream |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of hypolactasia and lactose intolerance
Key exclusion criteria (6 listed)
- Diarrhea
- Previous gastrointestinal pathologies
- Current or recent intake of antibiotics, anti-inflammatory drugs, laxatives or drugs interfering with intestinal transit
- Alterations of intestinal anatomy or function
- Pregnancy
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 |
|---|---|---|
| Probiotic ice creamAlso: BifidiceOne portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (>10(exp7)/g) every day for 4 weeks | Dietary supplement | Probiotic |
| Placebo ice creamAlso: PlaceboOne portion (50g) of an ice-cream without probiotic every day for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Area under curve (AUC) of hydrogen in the HBT
Time frame: Day 15
Acute effect of the probiotic on hydrogen excretion after lactose ingestion
20 secondary outcomes
Area under curve (AUC) of hydrogen in the HBT
Time frame: Day 43
Area under curve (AUC) of hydrogen in the HBT
Time frame: Day 71
Fecal microbiota alpha-diversity
Time frame: Days 15
Fecal microbiota alpha-diversity
Time frame: Day 43
Fecal microbiota alpha-diversity
Time frame: Day 71
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Time frame: Day 15
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Time frame: Day 43
Relative abundancies of the bacterial taxa forming the the fecal microbiota
Time frame: Day 71
Fecal counts of B. bifidum 900791
Time frame: Days 15
Fecal counts of B. bifidum 900791
Time frame: Days 43
Fecal counts of B. bifidum 900791
Time frame: Days 71
Fecal beta-galactosidase activity
Time frame: Days 15
Fecal beta-galactosidase activity
Time frame: Days 43
Fecal beta-galactosidase activity
Time frame: Days 71
Fecal short chain fatty acids concentrations
Time frame: Days 15
Fecal short chain fatty acids concentrations
Time frame: Days 43
Fecal short chain fatty acids concentrations
Time frame: Days 71
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Time frame: Days 15
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Time frame: Days 43
Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT
Time frame: Days 71
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Results publication: PubMed 2119557Marteau P, Pochart P, Flourie B, Pellier P, Santos L, Desjeux JF, Rambaud JC. Effect of chronic ingestion of a fermented dairy product containing Lactobacillus acidophilus and Bifidobacterium bifidum on metabolic activities of the colonic flora in humans. Am J Clin Nutr. 1990 Oct;52(4):685-8. doi: 10.1093/ajcn/52.4.685.
- Results publication: PubMed 11423928Pelletier X, Laure-Boussuge S, Donazzolo Y. Hydrogen excretion upon ingestion of dairy products in lactose-intolerant male subjects: importance of the live flora. Eur J Clin Nutr. 2001 Jun;55(6):509-12. doi: 10.1038/sj.ejcn.1601169.
- Results publication: PubMed 8792277Jiang T, Mustapha A, Savaiano DA. Improvement of lactose digestion in humans by ingestion of unfermented milk containing Bifidobacterium longum. J Dairy Sci. 1996 May;79(5):750-7. doi: 10.3168/jds.S0022-0302(96)76422-6.
- Results publication: PubMed 22402407Almeida CC, Lorena SL, Pavan CR, Akasaka HM, Mesquita MA. Beneficial effects of long-term consumption of a probiotic combination of Lactobacillus casei Shirota and Bifidobacterium breve Yakult may persist after suspension of therapy in lactose-intolerant patients. Nutr Clin Pract. 2012 Apr;27(2):247-51. doi: 10.1177/0884533612440289. Epub 2012 Mar 8.
- Results publication: PubMed 25191315Turroni F, Duranti S, Bottacini F, Guglielmetti S, Van Sinderen D, Ventura M. Bifidobacterium bifidum as an example of a specialized human gut commensal. Front Microbiol. 2014 Aug 21;5:437. doi: 10.3389/fmicb.2014.00437. eCollection 2014.
- Results publication: PubMed 27451450Gargari G, Taverniti V, Balzaretti S, Ferrario C, Gardana C, Simonetti P, Guglielmetti S. Consumption of a Bifidobacterium bifidum Strain for 4 Weeks Modulates Dominant Intestinal Bacterial Taxa and Fecal Butyrate in Healthy Adults. Appl Environ Microbiol. 2016 Sep 16;82(19):5850-9. doi: 10.1128/AEM.01753-16. Print 2016 Oct 1.
- Results publication: PubMed 17320993Hsu CA, Yu RC, Lee SL, Chou CC. Cultural condition affecting the growth and production of beta-galactosidase by Bifidobacterium longum CCRC 15708 in a jar fermenter. Int J Food Microbiol. 2007 May 1;116(1):186-9. doi: 10.1016/j.ijfoodmicro.2006.12.034. Epub 2007 Jan 19.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic ice cream in people with Lactose Intolerance, run by University of Chile.
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 6 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: status not confirmed, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Gotteland, PhD (56-2-29786977, mgottela@med.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (AUC) of hydrogen in the HBT (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952988, which also lists 7 linked publications.
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 17 May 2019.