Effectiveness of lactase enzyme in subjects with lactase non-persistence

ISRCTN ISRCTN55840353
DOI https://doi.org/10.1186/ISRCTN55840353
Secondary identifying numbers N/A
Submission date
05/04/2010
Registration date
19/05/2010
Last edited
19/05/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yulia Khabarova
Scientific

Timme Str. 9-3-119
Archangelsk
163060
Russian Federation

+7 (0)921 487 3632
Yuliakaterina@rambler.ru

Study information

Study designRandomised double-blind placebo-controlled 2 x 2 cross-over single centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effectiveness of lactase enzyme in subjects with lactase non-persistence (LNP): a randomised double-blind placebo-controlled 2 x 2 cross-over study
Study objectivesThere are differences in gastrointestinal symptoms after milk consumption between subjects with lactase non-persistence using lactase enzyme or placebo in a randomised double-blind setting.
Ethics approval(s)Ethics Committee of Northern State Medical University approved on the 12th February 2010 (ref: 03/02)
Health condition(s) or problem(s) studiedAdult-type hypolactasia
InterventionThe 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. As a result about 150 subjects had C/C-13910 genotype (lactase non-persistent genotype, adult-type hypolactasia). Medical students aged 17 to 26 years in quantity up to 120 subjects will be taken into this randomised double-blind placebo-controlled 2 x 2 cross-over study to estimate the effectiveness of lactase enzyme. All of them will be asked for written informed consent.

The explanation about the aim and (order) practical conduction of study will be given orally before the start. Moreover students will get a booklet with information about lactose non-persistence and lactose-containing products. All participants will be asked to avoid lactose-containing products 2 days before study and 3 hours after the intervention. The study will start in the morning.

Every subject has to fast overnight before the intervention. 500 ml of milk together with 2 capsules (lactase enzyme or placebo) will be given to the subjects in a randomised manner. After that every person will have to fill in a table with possible gastrointestinal symptoms and hourly mark a number according to the scale of severity. Subjects are not allowed to consume any food during three hours after the milk load. After three hours, all subjects will be provided the same lunch.

After a wash-out period of 1 week, students will come back, and the second period of the study will be conducted similarly to the first one (500 ml of milk + lactase enzyme or placebo). The estimation of symptom severity and fasting before and after the intervention will be done similarly as during the first intervention period.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Lactase enzyme
Primary outcome measureFive 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 outcome measuresNo secondary outcome measures
Overall study start date06/04/2010
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target number of participants92
Key inclusion criteria1. 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
Key exclusion criteria1. Inability or refusal to sign informed consent
2. Students younger or older than age of study group
Date of first enrolment06/04/2010
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • Russian Federation

Study participating centre

Timme Str. 9-3-119
Archangelsk
163060
Russian Federation

Sponsor information

Funders

Funder type

Industry

Oy Verman Ab (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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