Lactose IntoleranceNCT02518295
β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion
A study testing Probiotic S. thermophilus and Probiotic B. longum in people with Lactose Intolerance, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- Probiotic S. thermophilus and Probiotic B. longum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to Sep 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HBT> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests
- Having signed the informed consent or having provide his/her legal representative's informed consent
Who cannot join
- Known Food allergy
- Any obstructive (COPD, asthma…) or restrictive respiratory syndrome that may impact breath test measurements
- Any medically relevant malabsorption syndrome
- Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire
- Ongoing therapy with drugs known to affect gut motility
- Any general antibiotherapy taken during or within 4 weeks of study onset
Show all 11Show fewer
- Use of lactase pill (eg. Lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to Visit 0b
- Subject who cannot be expected to comply with the study procedures
- Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
- To be a close collaborator to the Investigators, either in terms of Family relationship and/or professional relationship
- Pregnancy, based on anamnesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance
The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.
Read the detailed description
The trial will be cross over, randomized in incomplete blocks, controlled, double-blind:
each subject will be administered 3 products out of 4 (positive control, probiotic Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge.
The total sample size is 42 enrolled subjects/37 completed Patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.
- Conditions
- Lactose Intolerance
- Being tested
- Positive control, Probiotic S. thermophilus, Probiotic B. longum, Negative control
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive controlOther
200ml milk containing 18g lactose
Probiotic S. thermophilusOther
200ml milk containing 18g lactose + probiotic S. thermophilus
Probiotic B. longumOther
200ml milk containing 18g lactose + probiotic B. longum
Negative controlOther
200 ml of UHT Lactose free milk
| Study group | Role | What they receive |
|---|---|---|
| Positive control | Active comparator | Ultra high temperature (UHT) milk containing 18 g total lactose Receives: Other: Positive control |
| Positive control with S. thermophilus | Active comparator | UHT milk containing 18 g total lactose+ S. thermophilus Receives: Other: Probiotic S. thermophilus |
| Positive control with B. longum | Active comparator | UHT milk containing 18 g total lactose+ B. longum Receives: Other: Probiotic B. longum |
| Negative control | Placebo comparator | Lactose free milk Receives: Other: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT)
Measured: HBT measured every hour during 4 hours after challenge (HBT curve)
Secondary outcomes (1)
Assessment of improvement of lactose intolerance symptoms using a composite score equal to the sum of individual symptoms measured using a visual analog scale (VAS)
Measured: 4 hours after every milk intake, from the time of ingestion up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionSep 2016
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.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stéphane Duboux, Study director, Société des Produits Nestlé (SPN)Gabriela Bergonzelli, PhD, Study director, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518295
- Sponsor's protocol ID
- 14.33. MET
- Status last verified
- Nov 2016
- First submitted
- 16 Jul 2015
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance
- ClinicalTrials.gov ID
- NCT02518295
- Acronym / sponsor ID
- 14.33. MET
- Conditions
- Lactose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- 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.
The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.
Detailed description
The trial will be cross over, randomized in incomplete blocks, controlled, double-blind:
each subject will be administered 3 products out of 4 (positive control, probiotic Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge.
The total sample size is 42 enrolled subjects/37 completed Patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive control | Active comparator | Other: Positive controlUltra high temperature (UHT) milk containing 18 g total lactose |
| Positive control with S. thermophilus | Active comparator | Other: Probiotic S. thermophilusUHT milk containing 18 g total lactose+ S. thermophilus |
| Positive control with B. longum | Active comparator | Other: Probiotic B. longumUHT milk containing 18 g total lactose+ B. longum |
| Negative control | Placebo comparator | Other: Negative controlLactose free milk |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HBT> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests
- Having signed the informed consent or having provide his/her legal representative's informed consent
Key exclusion criteria (11 listed)
- Known Food allergy
- Any obstructive (COPD, asthma…) or restrictive respiratory syndrome that may impact breath test measurements
- Any medically relevant malabsorption syndrome
- Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire
- Ongoing therapy with drugs known to affect gut motility
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 |
|---|---|---|
| Positive control200ml milk containing 18g lactose | Other | Positive control |
| Probiotic S. thermophilus200ml milk containing 18g lactose + probiotic S. thermophilus | Other | Positive control with S. thermophilus |
| Probiotic B. longum200ml milk containing 18g lactose + probiotic B. longum | Other | Positive control with B. longum |
| Negative control200 ml of UHT Lactose free milk | Other | Negative control |
Primary outcome
Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT)
Time frame: HBT measured every hour during 4 hours after challenge (HBT curve)
1 secondary outcome
Assessment of improvement of lactose intolerance symptoms using a composite score equal to the sum of individual symptoms measured using a visual analog scale (VAS)
Time frame: 4 hours after every milk intake, from the time of ingestion up to 5 hours
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 30 Nov 2016.
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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.
Stéphane Duboux study director
Société des Produits Nestlé (SPN)
Gabriela Bergonzelli, PhD study director
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic S. thermophilus and Probiotic B. longum in people with Lactose Intolerance, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 2 inclusion and 11 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 30 Nov 2016. 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 Switzerland. 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?
Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT) (time frame: HBT measured every hour during 4 hours after challenge (HBT curve)). 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 30 Nov 2016.