Health Condition 1: null- Lactose intolerance
Conditions
Interventions
Intervention1: Lactase chewable enzyme 4500 FCC: Lactase Enzyme (Derived from Aspergillus oryzae)
Route :Oral
Patient will be dosed one time on the day of Lactose hydrogen breath test.
Control Interve
Sponsors
Walter Bushnell Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The patient should be a male or female, aged between 18 and 65 years old Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air To be able to meet the study instructions and all the visits required. To give a free consent to participate in the study and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I. Exhaled hydrogen concentration 90 minutes after the ingestion of 25 g of lactose (with or without lactase) measured on day of test.Timepoint: 8HRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Exhaled hydrogen concentration over 180 minutes on test Day II.Scores for specific symptoms (Abdominal pain, Bloating, Nausea, Flatulence, Borboygmi, Diarrhoea) recorded during the hydrogen breath test and evaluated through a visual analogue scale (VAS, 0 [absent] to 10 [most intense possible]). Safety endpointsTimepoint: 8HRS | — |
Countries
India
Contacts
Public ContactDr Arun Prashant Baxla
Walter Bushnell Pvt Ltd, Delhi
Outcome results
None listed