The safety and gastro-intestinal tolerance of recombinant human lactoferrin (rhLF) in apparently healthy human volunteers
- Conditions
- gut health10017977gastro-intestinal tolerance
- Registration Number
- NL-OMON34362
- Lead Sponsor
- Pharming Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Healthy as assessed by the
- TNO health and lifestyle questionnaire, (P8896 F02; in Dutch)
- results of the pre-study safety laboratory tests
2. Volunteers aged > 25 and < 50 years at Day 01 of the study (gender distribution ideally 50%-50%, must not exceed 40%-60%)
3. Body Mass Index (BMI) 18-28 kg/m2
4. Regular and normal Dutch eating habits as assessed by P8896 F02
5. Voluntary participation
6. Having given written informed consent
7. Willing to comply with the study procedures
8. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years
9. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
3. Having a history of medical or surgical events that may significantly affect the study outcome
4. Frequent and/or intense sports practice (more than 10 hours/week)
5. Smoking
6. Alcohol consumption > 21 units/week for males and > 14 units/week for females.
7. Any history of any allergy, sensitivity or anaphylaxis, especially if related (but not limited) to food products (e.g. chocolate, wheat, dairy products, or milk-derived products, egg, nuts, etc.) and seasonal allergy (e.g. hay fever)
8. Current or intermittent gastro-intestinal complaints (stomach upsets, diarrhoea, constipation, flatulence, abdominal colic, etc.), or any known gastro-intestinal disorder (e.g. ulcerative colitis, Crohn*s disease)
9. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
10. Use of antibiotics or laxatives within 1 month before day 01 of the study
11. Reported slimming or medically prescribed diet
12. Reported vegan, vegetarian or macrobiotic
13. Pregnant or lactating female or wishing to become pregnant in the period of the study
14. Females not using acceptable contraception
15. Recent blood donation (<1 month prior to the start of the study)
16. Not willing to give up blood donation during the study.
17. Personnel of TNO Quality of Life location Zeist, their partner and their first and second degree relatives
18. Not having a general practitioner
19. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters are clinical laboratory and gastro-intestinal tolerance<br /><br>as measured by questionnaires. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are human lactoferrin (hLF) in faeces and blood, and<br /><br>anti-hLF antibodies in blood</p><br>