primary lactase deficiency MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: LACDIGEST
Pharmaceutical Form: Tablet
INN or Proposed INN: Tilactase
Concentration unit: U unit(s)
Concentration number: 2250-
Pharmaceutical form of the placebo: Tablet
Route of administr
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with persisting symptoms (i.e. longer than 6 months) located either in the upper and/or lower abdomen suggestive of lactose intolerance, fructose intolerance, small intestinal bacterial overgrowth (SIBO), functional gastrointestinal disorders (i.e. irritable bowel, functional dyspepsia, functional diarrhea) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects with alarm symptoms (e.g. anaemia, unexplained weight loss, chronic pain, ineffective therapies) or older than 50 years will be further investigated with upper a/o lower endoscopy and blood tests in order to rule out inflammatory bowel diseases, celiac disease, intestinal neoplasms, colonic diverticula, and thyroid diseases. If needed, patients will undergo Rx barium enema for characterization of colonic diverticula and severe dolicocolon, as a potential cause of lower intestinal symptoms. Excluded from the study will be also non-compliant subjects or those with an history of liver, renal, lung, heart, metabolic, or neurological disease and those taking laxatives, antibiotics, prokinetics, or any other drug known to influence colonic flora or gastrointestinal motility in the month preceding the study. All patients with known causes of secondary osteoporosis other than lactose intolerance will be not included in the soubgroup evaluating bone markers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy of two different doses (low, standard) of tilattase enzymes on gastrointestinal symptoms and hydrogen excretion in subjects with primary lactase deficiency.;Secondary Objective: Due to the chronic features of the primary lactase deficiency, to assess the outcome of prolonged treatment with tilactase enzymes on: gastrointestinal symptoms, quality of life, markers of osteopoenia/osteoporosis;Primary end point(s): breath H2 excretion and gastrointestinal symptoms | — |
Countries
Italy
Outcome results
None listed