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Effectiveness of lactase enzyme in subjects with lactase non-persistence

The effectiveness of lactase enzyme in subjects with lactase non-persistence (LNP): a randomised double-blind placebo-controlled 2 x 2 cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55840353
Enrollment
92
Registered
2010-05-19
Start date
2010-04-06
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult-type hypolactasia Nutritional, Metabolic, Endocrine Lactose intolerance

Interventions

The study sample includes the group of students from Northern State Medical University. All subjects have previously undergone genotyping for detection of lactase persistent/non-persistent genotype. A

Sponsors

Oy Verman Ab (Finland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Students from medical university with previously confirmed lactase non-persistent genotype (C/C-13910), aged 17 - 26 years, either sex 2. Students are included into study regardless of previous diseases, gastrointestinal symptoms, either connected or not with milk intake 3. All subjects will be fasting overnight before study and will be asked to avoid lactose content products 2 days before the study 4. Subjects will be asked to avoid lactose-containing food during 3 hours after the milk load with lactase enzyme or placebo

Exclusion criteria

Exclusion criteria: 1. Inability or refusal to sign informed consent 2. Students younger or older than age of study group

Design outcomes

Primary

MeasureTime frame
Five symptoms connected to lactose intolerance will be estimated by using the scale of severity where 1 is the minimal severity and 10 is maximum. Zero means no symptom. Subjects will fill in the table of severity of symptoms before intervention, 1 hour, 2 hours and 3 hours after the intervention and the rest of day after lunch.

Secondary

MeasureTime frame
No secondary outcome measures

Countries

Russian Federation

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026