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

actoResearch sprl0 个研究点开始时间: 2016年7月12日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- Age: 45 years, <65 years.
•- Patient Agreement with written consent.
•- diagnosis of lactose intolerance based on a breath testing (13C-lactose or hydrogen (+ CH4 + CO2) breath test with a dose of 25g of lactose): cumulative recovery of 13CO2 less than 15% for 3 hours, or an increase in the concentration of hydrogen expired more than 20 ppm or 10 ppm when two consecutive measurements during the test of 4 hours compared to the fasting state.
•The alveolar air samples are taken every 20 minutes until 60 minutes and then every 30 minutes until 240 minutes for the H2 test (+ CH4 + CO2).
•- Patient with a minimum average symptom score of 5/10 (bloating, abdominal pain, flatulence, diarrhea) during breath test.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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.
•- Noncompliant patients.

发起方

actoResearch sprl