Dose-escalation study to evaluate safety and tolerability of cellobiose in healthy subjects
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00012972
- Lead Sponsor
- Pfeifer & Langen GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
1. Men and women, 18 to 65 years old
2. BMI 18.5 to 29.9 kg/m2
3. Generally in good health without clinically significant findings at V1
4. Readiness to comply with study procedures, in
particular:
- consumption of the IP as recommended
- filling in the subject diary and questionnaire
- keeping habitual diet and level of physical
exercise and avoiding excessive exercise
- avoiding food that contains indigestible or less digestible ingredients such as oligosaccharides or sugar alcohols
- avoiding intake of yogurt
5. Women of childbearing potential:
- negative pregnancy testing (beta HCGtest
in urine) at V1
- commitment to use contraception methods during the study.
Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
1. Known allergy or hypersensitivity to the components of the investigational product
2. History and/or presence of clinically significant self-reported disorder as per investigator’s judgement:
- untreated or non-stabilized thyroid gland disorder
- untreated or non-stabilized Hypertension (regular systolic blood pressure =
140 mmHg and/or diastolic blood pressure = 90 mmHg)
- digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, pancreatitis
etc.)
- food allergy and known food intolerances (e.g. lactose, fructose)
- diarrhea within the preceding week or reported recurrent diarrhea
- any other organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
3. Gastrointestinal Symptom Rating Scale (GSRS) at V1 (1 week recall)
- any symptom scoring > 3
- total mean score > 2
4. Deviation of laboratory parameter(s) at V1 that is:
- clinically significant or
- 2x ULN/LLN (upper limit of normal/ lower limit of normal), unless the deviation is justified by a previous known not clinically relevant condition, e.g. Gilbert’s syndrome
5. Any regular medication and/or Supplementation that could interfere with the conduct / evaluation of the trial as per investigator’s
judgement
6. Previous relevant bowel surgery according to the investigator’s judgement
7. Pregnancy or nursing
8. History of or current abuse of drugs, alcohol or medication
9. Plans to travel during the study period
10. Participation in another clinical study in the
30 days prior to V1 and during the study
11. Any other reason for exclusion as per investigator’s judgement, e.g. insufficient compliance with study procedures
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of transient diarrhea (=Bristol Stool Form Scale (BSFS) = 7) between V2 and V3
- Secondary Outcome Measures
Name Time Method