Healthy volunteers
Conditions
Interventions
Group 1: The study is splitted into 2 phases. In the first phase (single-ascending-dose, SAD) 4 Groups of 6 subjects each will receive escalating dosages of cellobiose successively (10g, 15g, 20g, 25g
Sponsors
Pfeifer & Langen GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of transient diarrhea (=Bristol Stool Form Scale (BSFS) = 7) between V2 and V3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of transient diarrhea (=BSFS = 7) between V2 and V3 • Changes in mean bowel movement frequency assessed in subject diary between the last 3 days before each V2 and V3 • Daily bowel movement frequency assessed in subject diary between V2 and V3 • Changes in bowel movement consistency assessed by BSFS in subject diary between the last 3 days before each V2 and V3 • Daily bowel movement consistency assessed by BSFS in subject diary between V2 and V3 • Changes in gastrointestinal well-being assessed by Gastrointestinal Symptom Rating Scale (GSRS) in subject diary between the last 3 days before each V2 and V3 • Daily gastrointestinal well-being assessed by GSRS in subject diary between V2 and V3 • Changes in mean bowel movement frequency assessed in subject diary between the last 3 days before each V2 and the first 3 days after each V2 • Changes in bowel movement consistency assessed by BSFS in subject diary between the last 3 days before each V2 and the first 3 days after each V2 • Changes in gastrointestinal well-being assessed by GSRS in subject diary between the last 3 days before each V2 and the first 3 days after each V2 • Changes in occurrence of headache and thirst assessed by subject diary between the last 3 days before each V2 and the first 3 days after each V2 • Changes in occurrence of headache and thirst assessed by subject diary between the last 3 days before each V2 and V3 • Daily occurrence of headache and thirst assessed by subject diary between V2 and V3 • Time to onset of any events documented in the subject diary including the time point of the onset (after IP intake) • Global evaluation of tolerability by the subjects at study end • Global evaluation of tolerability by the investigators at study end • Assessment of adverse events throughout the study • Differences in blood pressure / pulse rate between V2 and V3 • Differences in body weight and BMI between V2 and V3 • Differences in safety laboratory parameters between V1 and V3 | — |
Countries
Germany
Contacts
Public ContactElisa Postrach
analyze & realize GmbH
Outcome results
None listed