Gastrointestinal SymptomsNCT03659747
Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk
A study testing Probiotic and Lactrase in people with Gastrointestinal Symptoms and Breath Test, run by Danisco at 1 site in Germany.
Trial summary
The main objective of the study is to investigate the effect of probiotic supplementation on lactose maldigestion. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Gastrointestinal Symptoms, Breath Test
- What is being tested?
- Probiotic and Lactrase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2018to 21 Dec 2018
- 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 60 years
- All sexes
- No healthy volunteers
- 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 or medically diagnosed lactose intolerance
- Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting breath hydrogen value at V2
- 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 and two weeks before Visit 3 (2 weeks after pre-screening visit)
- Females of child-bearing potential who agree to use a medically approved methods 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 months) 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 20Show 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))
- Use of tobacco, snuff, nicotine and e-cigarette
- History of or current abuse of drugs, alcohol or medication (self- reported)
- Self-declared use of illicit drugs
- 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
- Abnormal values in safety blood tests at V1 i.e. clinically significant or >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk: Randomized, Double-blind, Placebo-controlled, Crossover, Acute Lactose Challenge
The main objective of the study is to investigate the effect of probiotic supplementation on lactose maldigestion.
Read the detailed description
Primary endpoint is defined as the difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo and non-inferiority in breath hydrogen concentration (BHC, ppm) in probiotic group compared to lactase group, measured by the incremental area under curve (iAUC) analysis.
To characterize the benefit of the investigational product (IP) the following secondary endpoints will be analyzed:
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 V1 (following single nucleotide polymorphism (SNP) variants to be screened: -13910*C (Europe, Central Asia, commonly used) -13915*T (Saudi-Arabia, Africa), -14010*C (Africa), -13907*C (Africa))
- Conditions
- Gastrointestinal Symptoms, Breath Test
- Being tested
- Probiotic, Lactrase, Placebo
- Keywords
- Lactose maldigestion, gastrointestinal, Single-nucleotide polymorphism, probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
- 6 g sachet containing probiotic powder (1.8 x 10^12 CFU Probiotic) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit.
LactraseDietary supplement
- 6 g sachet containing 4500 Food Chemical Codex (FCC) units of lactase (Lactrase, Oy Verman Ab, Kerava, Finland) and maltodextrin as a carrier - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit.
PlaceboOther
- 6 g sachet containing placebo powder (maltodextrin) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat- free milk once in the beginning of a 6-hour challenge at a study visit.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | * 6 g sachet containing probiotic powder (1.8 x 10^12 colony forming units (CFU) Probiotic) in sachet
* One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. Receives: Dietary Supplement: Probiotic |
| Lactrase | Active comparator | * 6 g sachet containing 4500 FCC units of lactase (Lactrase, Oy Verman Ab, Kerava, Finland) and maltodextrin as a carrier
* One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. Receives: Dietary Supplement: Lactrase |
| Placebo | Placebo comparator | * 6 g sachet containing placebo powder (maltodextrin) in sachet
* One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. 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, measured by the iAUC analysis
Measured: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis
Measured: approximately 40 days
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis
Measured: approximately 40 days
Secondary outcomes (18)
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
Measured: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
Measured: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
Measured: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
Measured: approximately 40 days
Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the severity of nausea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Measured: approximately 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start11 Sep 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
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 Gastrointestinal SymptomsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Randomized, double-blind, placebo-controlled, parallel-group study
- 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)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
- Investigators
- Ralf Uebelhack, Prof. MD, Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659747
- Sponsor's protocol ID
- NH-03977
- Status last verified
- Mar 2019
- First submitted
- 3 Sep 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 5 Mar 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 Fat-free Milk: Randomized, Double-blind, Placebo-controlled, Crossover, Acute Lactose Challenge
- ClinicalTrials.gov ID
- NCT03659747
- Acronym / sponsor ID
- NH-03977
- Conditions
- Gastrointestinal Symptoms, Breath Test
- Keywords
- Lactose maldigestion, gastrointestinal, Single-nucleotide polymorphism, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 6 Sep 2018 (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.
The main objective of the study is to investigate the effect of probiotic supplementation on lactose maldigestion.
Detailed description
Primary endpoint is defined as the difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo and non-inferiority in breath hydrogen concentration (BHC, ppm) in probiotic group compared to lactase group, measured by the incremental area under curve (iAUC) analysis.
To characterize the benefit of the investigational product (IP) the following secondary endpoints will be analyzed:
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 V1 (following single nucleotide polymorphism (SNP) variants to be screened: -13910*C (Europe, Central Asia, commonly used) -13915*T (Saudi-Arabia, Africa), -14010*C (Africa), -13907*C (Africa))
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Crossover Assignment Randomized, double-blind, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic* 6 g sachet containing probiotic powder (1.8 x 10^12 colony forming units (CFU) Probiotic) in sachet * One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. |
| Lactrase | Active comparator | Dietary Supplement: Lactrase* 6 g sachet containing 4500 FCC units of lactase (Lactrase, Oy Verman Ab, Kerava, Finland) and maltodextrin as a carrier * One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. |
| Placebo | Placebo comparator | Other: Placebo* 6 g sachet containing placebo powder (maltodextrin) in sachet * One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 or medically diagnosed lactose intolerance
- Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting breath hydrogen value at V2
Key exclusion criteria (20 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 months) 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 |
|---|---|---|
| Probiotic- 6 g sachet containing probiotic powder (1.8 x 10^12 CFU Probiotic) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. | Dietary supplement | Probiotic |
| Lactrase- 6 g sachet containing 4500 Food Chemical Codex (FCC) units of lactase (Lactrase, Oy Verman Ab, Kerava, Finland) and maltodextrin as a carrier - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit. | Dietary supplement | Lactrase |
| Placebo- 6 g sachet containing placebo powder (maltodextrin) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat- free milk once in the beginning of a 6-hour challenge at a study visit. | Other | Placebo |
Primary outcome
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by the iAUC analysis
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis
Time frame: approximately 40 days
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis
Time frame: approximately 40 days
18 secondary outcomes
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
Time frame: approximately 40 days
Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of nausea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
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 5 Mar 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: 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.
Ralf Uebelhack, Prof. MD principal investigator
analyze & realize GmbH
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 Lactrase in people with Gastrointestinal Symptoms and Breath Test, run by Danisco at 1 site in Germany.
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 20 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 5 Mar 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 Germany. 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, measured by the iAUC analysis (time frame: approximately 40 days). 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 NCT03659747, 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 5 Mar 2019.