NCT03814668

Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

Completed NA Last updated 13 August 2019

What this trial tests

NA trial testing Probiotic in Lactose Intolerance in 34 participants. Completed in 30 April 2019.

Timeline

5 November 2018

Primary endpoint
30 April 2019

30 April 2019

Quick facts

Lead sponsor	Danisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	34
Start date	5 November 2018
Primary completion	30 April 2019
Estimated completion	30 April 2019
Sites	1 location across France

Drugs / interventions tested

• Probiotic
• Lactase — full drug profile →
• Placebo

Conditions studied

• Lactose Intolerance — all drugs for Lactose Intolerance →

Sponsor

Danisco — full company profile →

Who can join

Adults 25 to 65, any sex, with Lactose Intolerance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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))

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bifidobacterium animalis subsp. lactis Bi-07 supports lactose digestion in vitro and in randomized, placebo- and lactase-controlled clinical trials.
   Rasinkangas P, Forssten SD, Marttinen M, Ibarra A, et al · · 2022 · cited 7× · PMID 36149331 · DOI 10.1093/ajcn/nqac264