Lactose IntoleranceNCT03814668
Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution
A study testing Probiotic and Lactase in people with Lactose Intolerance, run by Danisco at 1 site in France.
Trial summary
Study objectives: Primary: Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo, measured by the incremental area under curve (iAUC) analysis Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group, measured by the… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- Probiotic and Lactase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2018to 30 Apr 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary, written, informed consent to participate in the study
- Agreement to comply with the protocol and study restrictions
- Healthy females and males of age 25 to 60 years (inclusive)
- Self-declared, suspected or medically diagnosed lactose intolerance
- Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting breath hydrogen value
- Participants who agree to maintain their usual dietary habits throughout the trial period
Show all 10Show fewer
- Participants who agree not to consume probiotics, prebiotics, fermented milk, and/or yogurt containing probiotics during the intervention period (Visits 3-5) and two weeks before Visit 3 (2 weeks after screening visit)
- Females of child-bearing potential who agree to use a medically approved method of birth control
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research
Who cannot join
- Gastrointestinal disorder or disease (e.g. Crohn's disease, ulcer, irritable bowel syndrome (IBS), Celiac disease, small intestinal bacterial overgrowth (SIBO), pancreatitis and disorders affecting gastrointestinal motility)
- Diagnosed type 1 or type 2 diabetes
- Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or affect study results
- Ongoing or recent (last 1 month) antibiotic treatment.
- Use of laxatives or drugs known to affect gut motility 1 month preceding the screening visit and during the study
- Ongoing or recurrent use of proton pump inhibitors
Show all 21Show fewer
- Colonoscopy within 3 months before screening
- History of recurrent colon cleansing and/or a colon cleansing within 3 months before screening
- Gastrointestinal infection within 1 month before screening or during the trial
- Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may affect the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)
- History of diagnosed coronary heart disease/cardiovascular disease or artificial heart valve
- Any obstructive or restrictive respiratory syndrome/disease that may impact breath test (e.g. asthma or chronic obstructive pulmonary disease (COPD))
- Regular use of tobacco, snuff, nicotine and e-cigarette, and possible other inhaled products. Light smokers (less than 5 cigarettes per day) who agree not to smoke during the whole duration of the study may be included.
- Self-declared history of alcohol abuse (for females: >3 drinks on any single day and >7 drinks per week; for males: >4 drinks on any single day and >14 drinks per week)
- Self-declared use of illicit drugs within 4 weeks preceding the screening visit
- Pregnant or lactating female, or pregnancy planned during study period
- Participants under administrative or legal supervision.
- Participation in another study with any investigational product within 60 days of screening
- Clinically significant abnormal values in safety blood tests at screening
- Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
- Who would receive more than 4500€ as indemnities for his participation in biomedical research within the last 12 months, including the indemnities for the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution: Randomized, Double-blind, Placebo-controlled, Positive-controlled, Three-way Crossover, Acute Lactose Challenge
Study objectives:
Primary:
Read more
Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo, measured by the incremental area under curve (iAUC) analysis
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group, measured by the incremental area under curve (iAUC) analysis
Secondary:
Breath test
- Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo
- Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo
Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert scale) in lactase and probiotic groups compared to placebo
- Abdominal pain
- Flatulence
- Bloating
- Nausea and vomiting
- Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol stool scale and number of bowel movements to be recorded)
Ancillary:
- Baseline fasting BHC (ppm)
- Breath methane CH4 (ppm)
- Breath carbon dioxide CO2 (ppm)
- Probiotic identification in feces before each lactose challenge by molecular methods
- Gene test to determine lactase deficiency status at screening (following SNP variants to be screened: 13910*C (Europe, Central Asia, commonly used) -22018*G (Europe), -13915*T (Saudi-Arabia, Africa), -14010*G (Africa), -13907*C (Africa))
- Conditions
- Lactose Intolerance
- Being tested
- Probiotic, Lactase, Placebo
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Intake of probiotic
LactaseDietary supplement
Intake of lactase
PlaceboOther
Intake of placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic powder | Experimental | One sachet of Probiotic powderwill be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits. Receives: Dietary Supplement: Probiotic |
| Lactase | Active comparator | One sachet of Lactase powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits. Receives: Dietary Supplement: Lactase |
| Placebo | Placebo comparator | One sachet of placebo powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo
Difference in breath hydrogen concentration (BHC, ppm) in probiotic compared to placebo, measured by the iAUC analysis
Measured: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis
Measured: During the 6-hour acute lactose challenge
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control)
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis
Measured: During the 6-hour acute lactose challenge
Secondary outcomes (18)
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
Measured: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
Measured: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
Measured: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
Measured: During the 6-hour acute lactose challenge
Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of abdominal pain in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the severity of nausea in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the severity of nausea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: During the 6-hour acute lactose challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start5 Nov 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814668
- Sponsor's protocol ID
- NH-03978
- Status last verified
- Aug 2019
- First submitted
- 20 Jan 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rasinkangas P, Forssten SD, Marttinen M, Ibarra A, Bothe G, Junnila J, Uebelhack R, Donazzolo Y, Ouwehand AC. Bifidobacterium animalis subsp. lactis Bi-07 supports lactose digestion in vitro and in randomized, placebo- and lactase-controlled clinical trials. Am J Clin Nutr. 2022 Dec 19;116(6):1580-1594. doi: 10.1093/ajcn/nqac264.
PubMed 36149331
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution: Randomized, Double-blind, Placebo-controlled, Positive-controlled, Three-way Crossover, Acute Lactose Challenge
- ClinicalTrials.gov ID
- NCT03814668
- Acronym / sponsor ID
- NH-03978
- Conditions
- Lactose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 24 Jan 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.
Study objectives:
Primary:
Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo, measured by the incremental area under curve (iAUC) analysis
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group, measured by the incremental area under curve (iAUC) analysis
Secondary:
Breath test
- Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo
- Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo
Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert scale) in lactase and probiotic groups compared to placebo
- Abdominal pain
- Flatulence
- Bloating
- Nausea and vomiting
- Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol stool scale and number of bowel movements to be recorded)
Ancillary:
- Baseline fasting BHC (ppm)
- Breath methane CH4 (ppm)
- Breath carbon dioxide CO2 (ppm)
- Probiotic identification in feces before each lactose challenge by molecular methods
- Gene test to determine lactase deficiency status at screening (following SNP variants to be screened: 13910*C (Europe, Central Asia, commonly used) -22018*G (Europe), -13915*T (Saudi-Arabia, Africa), -14010*G (Africa), -13907*C (Africa))
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic powder | Experimental | Dietary Supplement: ProbioticOne sachet of Probiotic powderwill be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits. |
| Lactase | Active comparator | Dietary Supplement: LactaseOne sachet of Lactase powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits. |
| Placebo | Placebo comparator | Other: PlaceboOne sachet of placebo powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary, written, informed consent to participate in the study
- Agreement to comply with the protocol and study restrictions
- Healthy females and males of age 25 to 60 years (inclusive)
- Self-declared, suspected or medically diagnosed lactose intolerance
- Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting breath hydrogen value
Key exclusion criteria (21 listed)
- Gastrointestinal disorder or disease (e.g. Crohn's disease, ulcer, irritable bowel syndrome (IBS), Celiac disease, small intestinal bacterial overgrowth (SIBO), pancreatitis and disorders affecting gastrointestinal motility)
- Diagnosed type 1 or type 2 diabetes
- Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or affect study results
- Ongoing or recent (last 1 month) antibiotic treatment.
- Use of laxatives or drugs known to affect gut motility 1 month preceding the screening visit and during the study
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 |
|---|---|---|
| ProbioticIntake of probiotic | Dietary supplement | Probiotic powder |
| LactaseIntake of lactase | Dietary supplement | Lactase |
| PlaceboIntake of placebo | Other | Placebo |
Primary outcome
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo
Time frame: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in probiotic compared to placebo, measured by the iAUC analysis
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo
Time frame: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control)
Time frame: During the 6-hour acute lactose challenge
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis
18 secondary outcomes
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
Time frame: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
Time frame: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
Time frame: During the 6-hour acute lactose challenge
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the severity of nausea in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: During the 6-hour acute lactose challenge
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 13 Aug 2019.
- Derived from this study: PubMed 36149331Rasinkangas P, Forssten SD, Marttinen M, Ibarra A, Bothe G, Junnila J, Uebelhack R, Donazzolo Y, Ouwehand AC. Bifidobacterium animalis subsp. lactis Bi-07 supports lactose digestion in vitro and in randomized, placebo- and lactase-controlled clinical trials. Am J Clin Nutr. 2022 Dec 19;116(6):1580-1594. doi: 10.1093/ajcn/nqac264.
- Individual participant dataSharing planned: Undecided
Related trials for Lactose Intolerance
Not yet recruiting
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
Cow Milk Protein Allergy, Cow Milk Intolerance
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
Enrolling by invitationObservational study
Lactose Intolerance and Intestinal Permability
Lactose Intolerance, Adult Type, Intestinal Permability
Not yet recruitingObservational study
Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
Lactose Intolerance
RecruitingPhase 3
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Irritable Bowel Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Lactase in people with Lactose Intolerance, run by Danisco at 1 site in France.
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 10 inclusion and 21 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 13 Aug 2019. 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 France. 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?
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo (time frame: During the 6-hour acute lactose challenge). The study lists 3 primary outcomes in all. 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 NCT03814668, which also lists 1 linked publication.
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 13 Aug 2019.