Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Proof of concept study to investigate the impact of a food supplement consisting of Acacia gum on changes of gut microbiota and production of short chain fatty acids. Additionally, safety, tolerability and parameters of bowel function (stool frequency, stool consistency and gastrointestinal symptoms) will be assessed during the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acacia gum | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acacia gum | Dietary Supplement | Two sachets (Ã 5 g) in the morning and two sachets in the evening, reconstituted in 120 ml water and stirred until fully dissolved to be taken 10 minutes before meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota | Composition and diversity (Shannon index), Lactobacillogenic and bifidogenic level, Distribution of bacterial taxa at the phylum, family and genus level, Shifts of specific bacterial taxa | day 1, day 43 and day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | frequency per week will be assessed via diary | day -14 (run-in phase) until day 70 (end of follow up) |
| Stool consitency | consistency will be assessed via Bristol Stool Form Scale |
Not provided
Inclusion Criteria:
Healthy subjects without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility
Constipation defined as an average of 2 - 3 stools per week (which needs to be confirmed during a prospective run-in phase)
At least one of the following criteria:
Criteria of constipation for at least the previous 3 months
BMI 18.5 - 30 kg/m2
Stable body weight (+/- 5%) in the last 3 months (self-reported)
Willing to maintain normal background dietary habits & physical activity levels throughout the study period
Written consent to participate in the study
Exclusion Criteria:
Relevant history or presence of any severe medical disorder, potentially interfering with this study in the investigator's judgement (e.g. mal absorption, food intolerance or allergy, chronic gastro-intestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa), chronic kidney or liver disease, severe depression, immunological disorders, severe cardiovascular disease, diabetes, acute malignant disease within last 3 years except basal cell carcinoma of the skin)
Prior abdominal surgery which may present a risk for the subject or confound the study results (according to the investigator's opinion)
Currently (or in the last 3 months) suffering from significant stress, anxiety or depression which, in the subjects opinion, interferes with normal daily life (e.g. has the subject missed days of work due to these conditions) and/or which could be responsible for gastrointestinal problems
Exclusively vegan or vegetarian diet (high fiber content)
Regular laxative use at least once per week
Use of hypolipidaemic drugs (e.g. statins, fibrates, resins, ezetimibe, niacin)
Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists, fibers etc.) within 2 weeks prior to study start or during the study; Stable medication (more than 3 months) for hypertension or thyroid gland is allowed.
Use of pre- and probiotic supplements
Subjects consuming
Smoker
Intake of antibiotics in the last 4 weeks
Pregnancy or breastfeeding (also exclude recent pregnancy in the last 3 months). A pregnancy test will be conducted during screening and visits 1 - 3.
Currently or recently (within 3 months of study entry) taking any medication, which in the opinion of the investigator, could interfere with the outcome of the study, e.g. opioids, anti-psychotics
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| day -14 (run-in phase) until day 70 (end of follow up) |
| Gastrointestinal symptoms | Global Gastrointestinal Discomfort Assessment (PAC-SYM), single gastrointestinal symptoms (flatulence, rumbling (i.e. borborygmi)), layative use | day -14 (run-in phase) until day 70 (end of follow up) |
| Blood biomarker | Lipid profile (total, HDL- and LDL- cholesterol and triglycerides) Blood glucose Electrolytes and minerals (plasma sodium, potassium and calcium) SCFA (short chain fatty acids) (optional) Cytokines: IL-10 & IL-6 (optional) | day 1, day 43 and day 71 |
| Stool biomarker | SCFA (short chain fatty acids) Zonulin Calprotectin (optional) Secretory IgA (optional) Beta-defensin (optional) Bile acids (optional) Nitric oxide (optional) | day 1, day 43 and day 71 |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |