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CompletedNCT03814668Updated Aug 13, 2019

Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

An interventional study of Probiotic and Lactase in Lactose Intolerance, sponsored by Danisco. Completed at 1 site in France. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by Danisco (part of International Flavors & Fragrances Inc.) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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 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))
02

Conditions studied

  • Lactose Intolerance

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03

In context

Lactose Intolerance

53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.

This study's enrollment of 34 is below the median of 41 across 41 interventional studies indexed under Lactose Intolerance.

Browse Lactose Intolerance studies →

Lead sponsor

Danisco is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

First submitted before Danisco became part of International Flavors & Fragrances Inc..

Browse Danisco studies →All International Flavors & Fragrances Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntary, written, to participate in the study
  2. Agreement to comply with the protocol and study restrictions
  3. Healthy females and males of age 25 to 60 years (inclusive)
  4. Self-declared, suspected or medically diagnosed lactose intolerance
  5. Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting breath hydrogen value
  6. Participants who agree to maintain their usual dietary habits throughout the trial period
  7. 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)
  8. Females of who agree to use a medically approved method of
  9. 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
  10. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. Diagnosed type 1 or type 2 diabetes
  3. Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or affect study results
  4. Ongoing or recent (last 1 month) antibiotic treatment.
  5. Use of laxatives or drugs known to affect gut motility 1 month preceding the screening visit and during the study
  6. Ongoing or recurrent use of proton pump inhibitors
  7. Colonoscopy within 3 months before screening
  8. History of recurrent colon cleansing and/or a colon cleansing within 3 months before screening
  9. Gastrointestinal infection within 1 month before screening or during the trial
  10. 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)
  11. History of diagnosed coronary heart disease/cardiovascular disease or artificial heart valve
  12. Any obstructive or restrictive respiratory syndrome/disease that may impact breath test (e.g. asthma or (COPD))
  13. 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.
  14. 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)
  15. Self-declared use of illicit drugs within 4 weeks preceding the screening visit
  16. Pregnant or lactating female, or pregnancy planned during study period
  17. Participants under administrative or legal supervision.
  18. Participation in another study with any product within 60 days of screening
  19. Clinically significant abnormal values in safety blood tests at screening
  20. Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
  21. 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Probiotic powder

    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.

    Dietary Supplement: Probiotic

  • Active comparator
    Lactase

    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.

    Dietary Supplement: Lactase

  • Placebo comparator
    Placebo

    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.

    Other: Placebo

Interventions

  • Dietary supplementProbiotic

    Intake of probiotic

  • Dietary supplementLactase

    Intake of lactase

  • OtherPlacebo

    Intake of placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During the 6-hour acute lactose challenge

  2. 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

    Time frame: During the 6-hour acute lactose challenge

  3. 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

    Time frame: During the 6-hour acute lactose challenge

Secondary outcomes

  1. 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

    Time frame: During the 6-hour acute lactose challenge

  2. 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

    Time frame: During the 6-hour acute lactose challenge

  3. 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

    Time frame: During the 6-hour acute lactose challenge

  4. 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

    Time frame: During the 6-hour acute lactose challenge

  5. 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

    Time frame: During the 6-hour acute lactose challenge

  6. 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

    Time frame: During the 6-hour acute lactose challenge

  7. 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

    Time frame: During the 6-hour acute lactose challenge

  8. 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

    Time frame: During the 6-hour acute lactose challenge

  9. 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

    Time frame: During the 6-hour acute lactose challenge

  10. 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

    Time frame: During the 6-hour acute lactose challenge

  11. 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

    Time frame: During the 6-hour acute lactose challenge

  12. 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

    Time frame: During the 6-hour acute lactose challenge

  13. 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

    Time frame: During the 6-hour acute lactose challenge

  14. 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

    Time frame: During the 6-hour acute lactose challenge

  15. 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

    Time frame: During the 6-hour acute lactose challenge

  16. 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

    Time frame: During the 6-hour acute lactose challenge

  17. 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

    Time frame: During the 6-hour acute lactose challenge

  18. 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

    Time frame: During the 6-hour acute lactose challenge

Other outcomes

  1. Difference in baseline fasting BHC (ppm) between the treatments

    Difference in baseline fasting BHC (ppm) between the treatments

    Time frame: Baseline

  2. Difference in breath methane concentration (ppm) between the treatments

    Difference in breath methane concentration (ppm) between the treatments

    Time frame: During the 6-hour acute lactose challenge

  3. Difference in breath carbon dioxide concentration (ppm) between the treatments

    Difference in breath methane concentration (ppm) between the treatments

    Time frame: During the 6-hour acute lactose challenge

  4. Difference in the quantity of probiotic in fecal samples between the treatments

    Difference in the quantity of probiotic in fecal samples between the treatments

    Time frame: 48-hours before the visits

  5. Description of the SNP variants in each treatment group

    Description of the SNP variants in each treatment group

    Time frame: At screening

07

Study locations

1 site
  • Eurofins Optimed
    Gières, 38610, France
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Apr 2019, 5 months.

Of 22 interventional studies with no phase under Lactose Intolerance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2019
First posted
Jan 24, 2019
StartActual
Nov 5, 2018
Primary completionActual
Apr 30, 2019
CompletionActual
Apr 30, 2019
Last update
Aug 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03814668
Lead sponsor
Danisco
Responsible party
Sponsor
First posted
Jan 24, 2019
Start date
Nov 5, 2018
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019
Last update
Aug 13, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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