Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/04/2010
Date assigned
19/05/2010
Last edited
19/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yulia Khabarova

ORCID ID

Contact details

Timme Str. 9-3-119
Archangelsk
163060
Russian Federation
+7 (0)921 487 3632
Yuliakaterina@rambler.ru

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

There 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

Ethics Committee of Northern State Medical University approved on the 12th February 2010 (ref: 03/02)

Study design

Randomised double-blind placebo-controlled 2 x 2 cross-over single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Adult-type hypolactasia

Intervention

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. 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 type

Drug

Phase

Not Specified

Drug names

Lactase enzyme

Primary outcome measures

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 outcome measures

No secondary outcome measures

Overall trial start date

06/04/2010

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

92

Participant exclusion criteria

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

Recruitment start date

06/04/2010

Recruitment end date

30/04/2010

Locations

Countries of recruitment

Russian Federation

Trial participating centre

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

Sponsor information

Organisation

Oy Verman Ab (Finland)

Sponsor details

PO Box 146
Kerava
FI-04201
Finland

Sponsor type

Industry

Website

http://www.verman.fi

Funders

Funder type

Industry

Funder name

Oy Verman Ab (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes