Evaluation of Lactosectan versus placebo to compare the effectiveness and safety in treating adult patients with intolerance to certain foods, primarily lactose intolerance

Phase 4

Completed

• Conditions: actose intolerance; Nutritional, Metabolic, Endocrine; Lactose intolerance

• Registration Number: ISRCTN18410689
• Lead Sponsor: ovintethical Pharma SA

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36076786/ (added 06/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-12
• Study Start: 2021-12-16
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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
11. Laxatives used for a colonoscopy within the last 2 weeks
12. Diabetic patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Efficacy evaluated in terms of:<br> 1. Tolerability of food intake assessed using a daily journal kept for the entire period of the study treatment<br> 2. Symptom reduction (bloating, distension, pain) assessed by the Likert scale using a daily journal kept for the entire period of the study treatment<br> 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)<br>

Secondary Outcome Measures

Name	Time	Method
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