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

Phase 1

Conditions: lactose intolerance
MedDRA version: 19.0Level: LLTClassification code 10023682Term: Lactose intolerantSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-001793-15-BE

Lead Sponsor: actoResearch sprl

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

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.