Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

NCT ID: NCT03814668

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2019-04-30

Brief 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))

Conditions

Lactose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Intake of probiotic

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.

Group Type: ACTIVE_COMPARATOR

Lactase

Intervention Type: DIETARY_SUPPLEMENT

Intake of lactase

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Intake of placebo

Interventions

Probiotic

Intake of probiotic

Intervention Type: DIETARY_SUPPLEMENT

Lactase

Intake of lactase

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intake of placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Voluntary, written, informed consent 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 child-bearing potential who agree to use a medically approved method of birth control

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

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. 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)

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 chronic obstructive pulmonary disease (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 investigational 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danisco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins Optimed

Gières, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36149331 (View on PubMed)

Other Identifiers

NH-03978

Identifier Type: -

Identifier Source: org_study_id