ISRCTN18410689
Completed
Phase 4
A double blind-cross-over, parallel, randomized, multicenter study to evaluate the safety and efficacy of LTS035 (Lactosectan) vs placebo in adult subjects with intolerance to certain foods, primarily lactose intolerant
ovintethical Pharma SA0 sites60 target enrollmentDecember 16, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- actose intolerance
- Sponsor
- ovintethical Pharma SA
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36076786/ (added 06/01/2023)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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