Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk

NCT03659747 | Completed

• 1 other identifier: NH-03977
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to investigate the effect of probiotic supplementation on lactose maldigestion.

Conditions

Gastrointestinal Symptoms; Breath Test

Keywords

Lactose maldigestion; gastrointestinal; Single-nucleotide polymorphism; probiotic

Outcome Measures

Primary Outcomes (3)

• Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by the iAUC analysis

  approximately 40 days

• Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis

  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

  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

  approximately 40 days

• Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value

  approximately 40 days

• Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value

  approximately 40 days

• Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value

  approximately 40 days

• Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey

  approximately 40 days

Other Outcomes (5)

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

  approximately 40 days

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

  approximately 40 days

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

  approximately 40 days

Study Arms (3)

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.

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.

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.

Other: Placebo

Interventions

Probiotic DIETARY_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.

Probiotic

Lactrase DIETARY_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.

Lactrase

Placebo OTHER

\- 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.

Placebo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 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
• 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

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 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
• 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

Sponsors & Collaborators

• Danisco: lead
• Analyze & Realize: collaborator

Study Sites (1)

analyze & realize GmbH

Berlin, 10369, Germany

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

Interventions

Probiotics; beta-Galactosidase

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ralf Uebelhack, Prof. MD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Crossover Assignment Randomized, double-blind, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: September 11, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)