Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

NCT03814668 | Completed

• 1 other identifier: NH-03978
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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

  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

  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

  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

  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

  During the 6-hour acute lactose challenge

Other Outcomes (5)

• Difference in baseline fasting BHC (ppm) between the treatments

  Baseline

• Difference in breath methane concentration (ppm) between the treatments

  During the 6-hour acute lactose challenge

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

  During the 6-hour acute lactose challenge

Study Arms (3)

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.

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.

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.

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Intake of probiotic

Probiotic powder

Lactase DIETARY_SUPPLEMENT

Intake of lactase

Lactase

Placebo OTHER

Intake of placebo

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Danisco: lead

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

Related Publications (1)

• 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.

  PMID: 36149331 DERIVED

MeSH Terms

Conditions

Lactose Intolerance

Interventions

Probiotics; Lactase

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 24, 2019
• Study Start: November 5, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

FR (1)