PROSPECTIVE STUDY OF THE EFFICIENCY OF PROBIOTIC MIXTURE TO IMPROVE LACTOSE DIGESTION AND SYMPTOMS OF LACTOSE INTOLERANCE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001793-15-BE

Enrollment

Unknown

Registered

2016-07-12

Start date

2016-07-12

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lactose intolerance MedDRA version: 19.0 Level: LLT Classification code 10023682 Term: Lactose intolerant System Organ Class: 100000004861

Interventions

Product Code: M5PR310 Pharmaceutical Form: Capsule INN or Proposed INN: Bifidobacterium longum subsp. infantis Current Sponsor code: THT 010201 Other descriptive name: BIFIDOBACTERIUM INFANTIS Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age: 45 years, =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with previous abdominal surgery, with the exception of an appendectomy, cholecystectomy and repair of parietal abdominal hernia. - history of inflammatory bowel disease. - Diagnosis of bacterial overgrowth of the small intestine - Diabetes - Patients suffering of progressive disease uncontrolled by medical treatment. - Pregnant or lactating women. - Use of probiotics in the 2 weeks preceding the study. - antibiotic use in the month before the study. - Use of lactase. - Recent loss of> 10 Kg. - Fever. - Noncompliant patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determining the efficacy of a mixture containing bifidobacter infantis tht010201, bifidobacter adolescentis tht010701, lactobacillus bulgaricus tht030301, Lactobacillus reuteri tht030802 and streptococcus thermophilus tht070102 at a concentration of 10 billion CFU to improve lactose digestion of patients intolerant to lactose.;Timepoint(s) of evaluation of this end point: evaluation visit of supplementation for two weeks;Secondary Objective: Determining the efficacy of a mixture containing bifidobacter infantis tht010201, bifidobacter adolescentis tht010701, lactobacillus bulgaricus tht030301, Lactobacillus reuteri tht030802 and streptococcus thermophilus tht070102 at a concentration of 10 billion CFU to improve gastrointestinal symptoms of patients intolerant to lactose.;Primary end point(s): Given the equipment available at the screening and evaluation visits, one of the two following criteria will be used: Significant increase (= 10%) of cumulative recovery rate of 13C02 following the administration of 13 C-lactose, with the probiotic mixture compared to basal values. Significant decrease (= 40%) of the total amount of hydrogen expired following the administration of lactose, with the probiotic mixture relative to baseline.	—

Measure

Time frame

Main Objective: Determining the efficacy of a mixture containing bifidobacter infantis tht010201, bifidobacter adolescentis tht010701, lactobacillus bulgaricus tht030301, Lactobacillus reuteri tht030802 and streptococcus thermophilus tht070102 at a concentration of 10 billion CFU to improve lactose digestion of patients intolerant to lactose.;Timepoint(s) of evaluation of this end point: evaluation visit of supplementation for two weeks;Secondary Objective: Determining the efficacy of a mixture containing bifidobacter infantis tht010201, bifidobacter adolescentis tht010701, lactobacillus bulgaricus tht030301, Lactobacillus reuteri tht030802 and streptococcus thermophilus tht070102 at a concentration of 10 billion CFU to improve gastrointestinal symptoms of patients intolerant to lactose.;Primary end point(s): Given the equipment available at the screening and evaluation visits, one of the two following criteria will be used: Significant increase (= 10%) of cumulative recovery rate of 13C02 following the administration of 13 C-lactose, with the probiotic mixture compared to basal values. Significant decrease (= 40%) of the total amount of hydrogen expired following the administration of lactose, with the probiotic mixture relative to baseline.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: evaluation visit of supplementation for two weeks;Secondary end point(s): In parallel to the breath test, a log of gastrointestinal symptoms validated will be used to assess the incidence and severity of symptoms of lactose intolerance. The severity of symptoms will be assessed using a visual analog scale of 10 cm, ranging from 0 (no symptoms) to 10 (worst possible) to which participants will mark the seriousness of 4 symptoms (bloating, abdominal pain, flatulence, diarrhea). The logbooks will be completed 4 times: at 3 and 6 hours after challenge with lactose during the visit of screening and at 3 and 6 hours after challenge with lactose after 2 weeks of supplementation. For each patient, a total score will be calculated on the basis of partial scores for each symptom. Patient compliance to the protocol is evaluated at the end of supplementation with a questionnaire and counting returned capsules during the evaluation visit of supplementation. The criteria for secondary judgments used in the analysis of results between the screening visit and assessment visit of supplementation with the probiotic mixture are: Change of the maximum average of 13CO2 expired for 3 hours. Proportion of patients with normalization of 13CO2 breath test. Change of the maximum average of hydrogen expired for 4 hours. Proportion of patients with normalization of hydrogen breath test. Change of the total score of severity of symptoms of lactose intolerance (LI SS) between the screening visit and the evaluation visit of supplementation in the group of patients treated with probiotic mixture. Change of the score of intensity of bloating (sub-score of LI SS) between screening visit and evaluation visit of supplementation. Change of the score of intensity of abdominal pain (sub-score of LI SS) between screening visit and evaluation visit of supplementation. Change of the score of intensity of flatulence (sub-score of LI SS) between scr	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: evaluation visit of supplementation for two weeks;Secondary end point(s): In parallel to the breath test, a log of gastrointestinal symptoms validated will be used to assess the incidence and severity of symptoms of lactose intolerance. The severity of symptoms will be assessed using a visual analog scale of 10 cm, ranging from 0 (no symptoms) to 10 (worst possible) to which participants will mark the seriousness of 4 symptoms (bloating, abdominal pain, flatulence, diarrhea). The logbooks will be completed 4 times: at 3 and 6 hours after challenge with lactose during the visit of screening and at 3 and 6 hours after challenge with lactose after 2 weeks of supplementation. For each patient, a total score will be calculated on the basis of partial scores for each symptom. Patient compliance to the protocol is evaluated at the end of supplementation with a questionnaire and counting returned capsules during the evaluation visit of supplementation. The criteria for secondary judgments used in the analysis of results between the screening visit and assessment visit of supplementation with the probiotic mixture are: Change of the maximum average of 13CO2 expired for 3 hours. Proportion of patients with normalization of 13CO2 breath test. Change of the maximum average of hydrogen expired for 4 hours. Proportion of patients with normalization of hydrogen breath test. Change of the total score of severity of symptoms of lactose intolerance (LI SS) between the screening visit and the evaluation visit of supplementation in the group of patients treated with probiotic mixture. Change of the score of intensity of bloating (sub-score of LI SS) between screening visit and evaluation visit of supplementation. Change of the score of intensity of abdominal pain (sub-score of LI SS) between screening visit and evaluation visit of supplementation. Change of the score of intensity of flatulence (sub-score of LI SS) between scr

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Countries

Belgium

Contacts

Public ContactFabienne Fonteyn

LactoResearch sprl

F.Fonteyn@lactoresearch.be32(0)81408630

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026