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
Not provided at time of registration
Contact information
Dr Yulia Khabarova
Scientific
Scientific
Timme Str. 9-3-119
Archangelsk
163060
Russian Federation
| Phone | +7 (0)921 487 3632 |
|---|---|
| Yuliakaterina@rambler.ru |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| 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(s) | Ethics Committee of Northern State Medical University approved on the 12th February 2010 (ref: 03/02) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lactase enzyme |
| Primary outcome measure | 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 study start date | 06/04/2010 |
| Overall study end date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 92 |
| 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 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
Study participating centre
Timme Str. 9-3-119
Archangelsk
163060
Russian Federation
163060
Russian Federation
Sponsor information
Oy Verman Ab (Finland)
Industry
Industry
PO Box 146
Kerava
FI-04201
Finland
| Website | http://www.verman.fi |
|---|---|
"ROR" |
https://ror.org/0116f3t39 |
Funders
Funder type
Industry
Oy Verman Ab (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
