ConstipationNCT04382456
Evaluation of Acacia Gum on Microbiome and Bowel Function in Participants With Chronic Constipation
A study testing acacia gum in people with Constipation, run by Alpinia Laudanum GmbH at 1 site in Germany.
Trial 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, tolerability and parameters of bowel function (stool frequency, stool consistency and gastrointestinal symptoms) will be assessed… Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- acacia gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to 7 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Pilot Study to Evaluate the Impact of Alpinia Acacia Gum on Microbiome and Bowel Function in Subjects With Chronic Constipation
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.
- Conditions
- Constipation
- Being tested
- acacia gum
- Keywords
- Acacia gum, gummi arabicum, microbiome, short chain fatty acids, SCFA, stool frequency, stool consitency
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acacia gumDietary supplement
Two sachets (à 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.
| Study group | Role | What they receive |
|---|---|---|
| acacia gum | Experimental | Not described Receives: Dietary Supplement: acacia gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1, day 43 and day 71
Secondary outcomes (5)
Stool frequency
frequency per week will be assessed via diary
Measured: day -14 (run-in phase) until day 70 (end of follow up)
Stool consitency
consistency will be assessed via Bristol Stool Form Scale
Measured: 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
Measured: 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)
Measured: 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)
Measured: day 1, day 43 and day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jun 2020
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpinia Laudanum GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382456
- Sponsor's protocol ID
- BTS1416/19
- Status last verified
- Aug 2020
- First submitted
- 7 May 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Pilot Study to Evaluate the Impact of Alpinia Acacia Gum on Microbiome and Bowel Function in Subjects With Chronic Constipation
- ClinicalTrials.gov ID
- NCT04382456
- Acronym / sponsor ID
- BTS1416/19
- Conditions
- Constipation
- Keywords
- Acacia gum, gummi arabicum, microbiome, short chain fatty acids, SCFA, stool frequency, stool consitency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alpinia Laudanum GmbHUniversity, hospital or other
- Collaborators
- BioTeSys GmbH
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acacia gum | Experimental | Dietary Supplement: acacia gum |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acacia gumTwo sachets (à 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. | Dietary supplement | acacia gum |
Primary outcome
Gut microbiota
Time frame: day 1, day 43 and day 71
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
5 secondary outcomes
Stool frequency
Time frame: day -14 (run-in phase) until day 70 (end of follow up)
Stool consitency
Time frame: day -14 (run-in phase) until day 70 (end of follow up)
Gastrointestinal symptoms
Time frame: day -14 (run-in phase) until day 70 (end of follow up)
Blood biomarker
Time frame: day 1, day 43 and day 71
Stool biomarker
Time frame: day 1, day 43 and day 71
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acacia gum in people with Constipation, run by Alpinia Laudanum GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: day 1, day 43 and day 71). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.