Lactose intolerance Nutritional, Metabolic, Endocrine Lactose intolerance
Conditions
Interventions
Subjects meeting all eligibility criteria will be randomized using a 1:1 ratio (Lactosectan: placebo) based on the randomization sequence and documented in the study file.
Group A wil
Sponsors
Novintethical Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 64 years with a current or recently reported history of dairy intolerance of at least 1-month duration 2. Caucasian race 3. Willing to sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women 2. Unwilling to sign the informed consent form 3. Allergy to one of the product ingredients 4. Cannot to come to the study visits 5. Patients with celiac disease 6. Patients with gastroenteritis 7. Patients with Crohn’s disease 8. Using lactase enzyme tablets or drops 9. Used antibiotics in the last 4 weeks 10. Used laxatives in the last 2 weeks 11. Laxatives used for a colonoscopy within the last 2 weeks 12. Diabetic patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluated in terms of: 1. Tolerability of food intake assessed using a daily journal kept for the entire period of the study treatment 2. Symptom reduction (bloating, distension, pain) assessed by the Likert scale using a daily journal kept for the entire period of the study treatment 3. Speed of action assessed using the hydrogen breath test (HBT) on V2 (day 1 of treatment), V3 (day 2 of treatment), V4 (end of first-line treatment and crossover) to V5 (after cross-over the first day of the second-line treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety of the LTS035 study formulation evaluated by monitoring the occurrence of undesirable effects reported by the patient or observed by the physician during the whole study period | — |
Countries
Romania
Outcome results
None listed