Status:
COMPLETED
Evaluation of Acacia Gum on Microbiome and Bowel Function in Participants With Chronic Constipation
Lead Sponsor:
Alpinia Laudanum GmbH
Collaborating Sponsors:
BioTeSys GmbH
Conditions:
Constipation
Eligibility:
FEMALE
25-60 years
Phase:
NA
Brief Summary
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, tolerabilit...
Eligibility Criteria
Inclusion
- 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:
- straining during more than 25% of defecations
- lumpy or hard stools (Bristol Stool Form Scale 1 or 2) present more than 25% of defecations
- sensation of incomplete evacuation in more than 25% of defecations
- sensation of anorectal obstruction/ blockage in more than 25% of defecations
- manual manoeuvre to facilitate more than 25% of defecations (such as digital evacuation or support from pelvic floor)
- 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
- 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
- food or drinks claimed as 'probiotic', or 'prebiotic more than once weekly
- food or drinks claimed as 'rich in fiber' (including specific milk products) more than 3 times per week
- more than 3 portions of fruits and vegetables (sum) per day
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04382456
Start Date
June 1 2020
End Date
September 7 2020
Last Update
January 12 2021
Active Locations (1)
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1
BioTeSys GmbH
Esslingen am Neckar, Germany, 73728