Gut MicrobiotaNCT04351841
To Investigate the Effect of Arabinogalactan on the Gut Microbiome in Adults
A study testing arabinogalactan and maltodextrin in people with Gut Microbiota, run by Biofortis, Merieux NutriSciences at 1 site in United States.
Trial summary
Dietary fiber is an important nutrient that supports gastrointestinal function, as well as the maintenance of blood glucose and cholesterol. Additionally, it is suggested that dietary fiber may provide other health benefits, such as maintenance of healthy weight through effects on satiety. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- arabinogalactan and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 18 Dec 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 18.0 to 32.0 kg/m2, inclusive, at Visit 1 (Week -1).
- Self-reported regular bowel movement at Visit 1 (Week -1).
- Non-user of all tobacco and smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes) and nicotine products (e.g., nicotine patches, nicotine gums) and has no plans to change smoking habits during the study period.
- Non-user of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period.
- Willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial, except for exclusion of fermented foods that do or might contain live probiotics (e.g., yogurt, kombucha) and inclusion of study products.
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to and during Visits 1, 2, 4, 5, and 7 (Weeks -1, 0, 6, 9, and 15).
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- Willing to refrain from exclusionary medications, supplements, and products throughout the study.
- Willing and able to comply with the visit schedule and fecal sample collection/processing/storage requirements during the study period.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- Abnormal laboratory test results of clinical significance at Visit 1 (Week -1), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Week 0), for subjects with abnormal laboratory test results.
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose and gluten intolerance or allergies).
- Recent (within 2 weeks of Visit 1; Week -1) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥3 loose or liquid stools/day).
- Self-reported history (within 6 weeks of Visit 1; Week -1) of constipation (defined as <3 bowel movements per week).
- History or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Week -1).
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- One re-test will be allowed on a separate day prior to Visit 2 (Week 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Week -1), in the judgment of the Clinical Investigator.
- Known allergy intolerances or sensitivity to any of the ingredients in the study product (Appendix 8).
- Extreme dietary habits (e.g., Atkins diet/ketogenic diet, very high protein, very high fiber, vegetarian), in the opinion of the Clinical Investigator.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Major trauma or any other surgical event within 3 months of Visit 1 (Week -1).
- Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Week -1). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Week -1). If an infection occurs during the study period, test visits will be rescheduled until all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to study visits.
- Weight loss or gain >4.5 kg in the 3 months prior to Visit 1 (Week -1).
- Currently or planning to be on a weight loss regimen during the duration of the study.
- Antibiotic use within 2 months of Visit 1 (Week -1).
- Use of steroids within 1 month of Visit 1 (Week -1).
- Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of Visit 1 (Week -1).
- Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to prebiotics or probiotics, laxatives, enemas, fiber supplements and/or suppositories, anti-diarrheal agents, and/or anti-spasmodic within 2 weeks of Visit 1 (Week -1).
- Bismuth subsalicylate (e.g., Pepto Bismol) and antacids (e.g., Tums) ≤2 times/ week starting from 2 weeks prior to Visit 1 (Week -1), with the exception of 7 days prior to the stool collection period, during which consumption of these products are not allowed.
- Consumption of fermented foods or beverages that do or might contain live probiotics (Appendix 1) within 2 weeks of Visit 1 (Week -1).
- Participated in colonoscopy or colonoscopy preparation within 3 months prior to Visit 1 (day -14).
- Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Week - 1).
- Recent history of (within 12 months of screening; Visit 1; Week -1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Effect of an Arabinogalactan Product for 6 Weeks on the Gut Microbiome in Adults
Dietary fiber is an important nutrient that supports gastrointestinal function, as well as the maintenance of blood glucose and cholesterol. Additionally, it is suggested that dietary fiber may provide other health benefits, such as maintenance of healthy weight through effects on satiety. Furthermore, dietary fiber can improve health by modulating the microbial communities residing in human gut, particularly in the large intestine. The microbes in the gut modulate a wide variety of biological processes essential for health of the host. Currently, the average intake of fiber in the U.S. is ~40-50% below adequate intake levels.
ResitAid, a Lonza's arabinogalactan, is a hemicellulose that is abundant in plants. Arabinogalactans including ResitAid are found in seeds, leaves, roots, and fruit of higher plants, such as cereals, beans, leeks, pear, corn, bark, and wheat. ResitAid, the arabinogalactan ingredient used in this study, is isolated from larch (Larix laricina) using a patented water-based extraction process. ResitAid has been designated as Generally Recognized as Safe (GRAS) by the U.S. FDA for multiple uses and has been used in numerous previous clinical studies in humans, with no significant safety issues observed at intakes of up to 30 g daily for up to 6 weeks. It was reported that 15 g and 30 g of different preparation of arabinogalactan could significantly increase certain microbial populations considered to be beneficial (e.g., Lactobacillus spp.). Nevertheless, more clinical evidence is needed to support the effect of ResistAid on the microbial composition in the gut. This study is designed to investigate the effect of daily consumption of 15 g of ResitAid on the gastrointestinal microbial profile and fecal short-chain fatty acid contents in healthy adults.
Read more
Primary Objective: Modulation of the microbiome
Secondary objectives:
- Changes in Lactobacillus ssp.
- Changes in Bifidobacterium ssp.
- Changes in SCFA
- Changes in bowel movement
- Changes in the SF-36 questionnaire
Read the detailed description
The study is a randomized, crossover, single-center trial with one screening visit (Visit 1; Week -1) and 2 test periods [Test Period I (Visits 2, 3, and 4; Weeks 0, 3, and 6) and Test Period II (Visits 5, 6, and 7; Weeks 9, 12 and 15)] separated by a minimum 3-week washout period.
At Visit 1 (Week -1), subjects will provide informed consent and undergo assessments of medical history and medication/supplement use, and inclusion and exclusion criteria. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Subjects will be counseled to exclude fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha). Subjects will also be dispensed a gastrointestinal (GI) and Bowel Habits Diary and stool collection kit. Subjects will be instructed to complete the GI and Bowel Habits Diary during the 3 days prior to Visit 2 (Week 0) and to collect fecal samples from one bowel movement during the 3 days prior to Visit 2 (Week 0).
At Visit 2 (Week 0), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures. Adverse events (AE) will be assessed and the SF-36 Questionnaire will be administered. Fecal samples will be collected and the GI and Bowel Habits Diary will be collected and reviewed. Subjects will be randomly assigned to a study product for home consumption with or without breakfast in the morning. Subjects will be dispensed a GI and Bowel Habits Diary and stool collection kit and will be instructed to complete the diary during the 3 days immediately prior to Visit 3 (Week 3) and to collect fecal samples from one bowel movement during the same 3 days immediately prior to Visit 3 (Week 3).
At Visit 3 (Week 3), subjects will return to the clinic for clinic visit procedures. AEs will be assessed and the SF-36 Questionnaire will be administered. The fecal samples will be collected and the GI and Bowel Habits Diary will be collected and reviewed. Study product will be re-dispensed back to subjects for home consumption. Subjects will be dispensed a GI and Bowel Habits Diary and stool collection kit and will be instructed to complete the diary during the 3 days immediately prior to Visit 4 (Week 6) and to collect fecal samples during the same period.
At Visit 4 (Week 6), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures. AEs will be assessed and the SF-36 Questionnaire will be administered. Subjects will be queried about compliance with study instructions. The fecal samples will be collected and GI and Bowel Habits Diary will be collected and reviewed. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Subjects will be dispensed a stool collection kit and will be instructed to collect fecal samples from one bowel movement during the 3 days immediately prior to Visit 5 (Week 9). Subjects will be instructed to begin the 3-week washout period and return to the clinic to begin Test Period II at Visit 5 (Week 9).
At Visit 5 (Week 9), subjects will return to the clinic fasted (12 ± 2 h, water only), crossover to the other study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exclusion of the randomization procedure. At Visit 6 (Week 12), subjects will repeat the procedures from Visit 3 (Week 3) and at Visit 7 (Week 15), subjects will repeat the procedures from Visit 4 (Week 6). Subjects will be dismissed at the end of Visit 7.
- Conditions
- Gut Microbiota
- Being tested
- arabinogalactan, maltodextrin
- Keywords
- microbiome, stool, indigestible carbohydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arabinogalactanOther
A beverage will be prepared by thoroughly mixing the 15 g of arabinogalactan with water and Crystal Light flavoring
maltodextrinOther
A beverage will be prepared by thoroughly mixing the 15 g of maltodextrin with water and Crystal Light flavoring
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 15 g maltodextrin per day consumed in the morning Receives: Other: maltodextrin |
| Active | Experimental | 15 g arabinogalactan per day consumed in the morning Receives: Other: arabinogalactan |
What is being measured
The primary outcome is the main question the study is designed to answer.
composition of fecal microbiome
relative abundance of bacteria and alpha- and beta-diversity
Measured: up to 6 weeks
Concentration of fecal short-chain fatty acids
acetate, butyrate, propionate, valerate, isobutyrate, and isovalerate contents (ug/g wet stool)
Measured: Change from the baseline at 6 weeks
Secondary outcomes (7)
Bowel Movement
Number per week
Measured: Change from the baseline at 6 weeks
stool consistency
Using Bristol Stool Scale [ranging from 1 (solid, hard) to 7 (losse)] to assess stool consistency for 7 days
Measured: Change from the baseline at 6 weeks
sensation of incomplete evacuation during bowel movement
self-assess for 7 days using a Likert 4-point scale
Measured: Change from the baseline at 6 weeks
straining during bowel movement
self-assess for 7 days using a Likert 4-point scale
Measured: Change from the baseline at 6 weeks
discomfort during bowel movement
self-assess for 7 days using a Likert 4-point scale
Measured: Change from the baseline at 6 weeks
general health status
SF-36 questionnaire measures general health status and health-related quality of life. The score ranges from 0 to 100 with the highest value indicating a favorable health state.
Measured: Change from the baseline at 6 weeks
Concentration of plasma short-chain fatty acids
acetate, butyrate, propionate, valerate, isobutyrate, and isovalerate contents (umol/L)
Measured: Change from the baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start5 Aug 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofortis, Merieux NutriSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lonza Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351841
- Sponsor's protocol ID
- BIO 1906
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 22 Apr 2020
- 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Effect of an Arabinogalactan Product for 6 Weeks on the Gut Microbiome in Adults
- ClinicalTrials.gov ID
- NCT04351841
- Acronym / sponsor ID
- BIO 1906
- Conditions
- Gut Microbiota
- Keywords
- microbiome, stool, indigestible carbohydrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biofortis, Merieux NutriSciencesIndustry (pharma, biotech, devices)
- Collaborators
- Lonza Inc.
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 17 Apr 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.
Dietary fiber is an important nutrient that supports gastrointestinal function, as well as the maintenance of blood glucose and cholesterol. Additionally, it is suggested that dietary fiber may provide other health benefits, such as maintenance of healthy weight through effects on satiety. Furthermore, dietary fiber can improve health by modulating the microbial communities residing in human gut, particularly in the large intestine. The microbes in the gut modulate a wide variety of biological processes essential for health of the host. Currently, the average intake of fiber in the U.S. is ~40-50% below adequate intake levels.
ResitAid, a Lonza's arabinogalactan, is a hemicellulose that is abundant in plants. Arabinogalactans including ResitAid are found in seeds, leaves, roots, and fruit of higher plants, such as cereals, beans, leeks, pear, corn, bark, and wheat. ResitAid, the arabinogalactan ingredient used in this study, is isolated from larch (Larix laricina) using a patented water-based extraction process. ResitAid has been designated as Generally Recognized as Safe (GRAS) by the U.S. FDA for multiple uses and has been used in numerous previous clinical studies in humans, with no significant safety issues observed at intakes of up to 30 g daily for up to 6 weeks. It was reported that 15 g and 30 g of different preparation of arabinogalactan could significantly increase certain microbial populations considered to be beneficial (e.g., Lactobacillus spp.). Nevertheless, more clinical evidence is needed to support the effect of ResistAid on the microbial composition in the gut. This study is designed to investigate the effect of daily consumption of 15 g of ResitAid on the gastrointestinal microbial profile and fecal short-chain fatty acid contents in healthy adults.
Primary Objective: Modulation of the microbiome
Secondary objectives:
- Changes in Lactobacillus ssp.
- Changes in Bifidobacterium ssp.
- Changes in SCFA
- Changes in bowel movement
- Changes in the SF-36 questionnaire
Detailed description
The study is a randomized, crossover, single-center trial with one screening visit (Visit 1; Week -1) and 2 test periods [Test Period I (Visits 2, 3, and 4; Weeks 0, 3, and 6) and Test Period II (Visits 5, 6, and 7; Weeks 9, 12 and 15)] separated by a minimum 3-week washout period.
At Visit 1 (Week -1), subjects will provide informed consent and undergo assessments of medical history and medication/supplement use, and inclusion and exclusion criteria. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Subjects will be counseled to exclude fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha). Subjects will also be dispensed a gastrointestinal (GI) and Bowel Habits Diary and stool collection kit. Subjects will be instructed to complete the GI and Bowel Habits Diary during the 3 days prior to Visit 2 (Week 0) and to collect fecal samples from one bowel movement during the 3 days prior to Visit 2 (Week 0).
At Visit 2 (Week 0), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures. Adverse events (AE) will be assessed and the SF-36 Questionnaire will be administered. Fecal samples will be collected and the GI and Bowel Habits Diary will be collected and reviewed. Subjects will be randomly assigned to a study product for home consumption with or without breakfast in the morning. Subjects will be dispensed a GI and Bowel Habits Diary and stool collection kit and will be instructed to complete the diary during the 3 days immediately prior to Visit 3 (Week 3) and to collect fecal samples from one bowel movement during the same 3 days immediately prior to Visit 3 (Week 3).
At Visit 3 (Week 3), subjects will return to the clinic for clinic visit procedures. AEs will be assessed and the SF-36 Questionnaire will be administered. The fecal samples will be collected and the GI and Bowel Habits Diary will be collected and reviewed. Study product will be re-dispensed back to subjects for home consumption. Subjects will be dispensed a GI and Bowel Habits Diary and stool collection kit and will be instructed to complete the diary during the 3 days immediately prior to Visit 4 (Week 6) and to collect fecal samples during the same period.
At Visit 4 (Week 6), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures. AEs will be assessed and the SF-36 Questionnaire will be administered. Subjects will be queried about compliance with study instructions. The fecal samples will be collected and GI and Bowel Habits Diary will be collected and reviewed. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Subjects will be dispensed a stool collection kit and will be instructed to collect fecal samples from one bowel movement during the 3 days immediately prior to Visit 5 (Week 9). Subjects will be instructed to begin the 3-week washout period and return to the clinic to begin Test Period II at Visit 5 (Week 9).
At Visit 5 (Week 9), subjects will return to the clinic fasted (12 ± 2 h, water only), crossover to the other study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exclusion of the randomization procedure. At Visit 6 (Week 12), subjects will repeat the procedures from Visit 3 (Week 3) and at Visit 7 (Week 15), subjects will repeat the procedures from Visit 4 (Week 6). Subjects will be dismissed at the end of Visit 7.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: maltodextrin15 g maltodextrin per day consumed in the morning |
| Active | Experimental | Other: arabinogalactan15 g arabinogalactan per day consumed in the morning |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- BMI of 18.0 to 32.0 kg/m2, inclusive, at Visit 1 (Week -1).
- Self-reported regular bowel movement at Visit 1 (Week -1).
- Non-user of all tobacco and smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes) and nicotine products (e.g., nicotine patches, nicotine gums) and has no plans to change smoking habits during the study period.
- Non-user of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period.
- Willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial, except for exclusion of fermented foods that do or might contain live probiotics (e.g., yogurt, kombucha) and inclusion of study products.
Key exclusion criteria (24 listed)
- Abnormal laboratory test results of clinical significance at Visit 1 (Week -1), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Week 0), for subjects with abnormal laboratory test results.
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose and gluten intolerance or allergies).
- Recent (within 2 weeks of Visit 1; Week -1) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥3 loose or liquid stools/day).
- Self-reported history (within 6 weeks of Visit 1; Week -1) of constipation (defined as <3 bowel movements per week).
- History or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
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 |
|---|---|---|
| arabinogalactanA beverage will be prepared by thoroughly mixing the 15 g of arabinogalactan with water and Crystal Light flavoring | Other | Active |
| maltodextrinA beverage will be prepared by thoroughly mixing the 15 g of maltodextrin with water and Crystal Light flavoring | Other | control |
Primary outcome
composition of fecal microbiome
Time frame: up to 6 weeks
relative abundance of bacteria and alpha- and beta-diversity
Concentration of fecal short-chain fatty acids
Time frame: Change from the baseline at 6 weeks
acetate, butyrate, propionate, valerate, isobutyrate, and isovalerate contents (ug/g wet stool)
7 secondary outcomes
Bowel Movement
Time frame: Change from the baseline at 6 weeks
stool consistency
Time frame: Change from the baseline at 6 weeks
sensation of incomplete evacuation during bowel movement
Time frame: Change from the baseline at 6 weeks
straining during bowel movement
Time frame: Change from the baseline at 6 weeks
discomfort during bowel movement
Time frame: Change from the baseline at 6 weeks
general health status
Time frame: Change from the baseline at 6 weeks
Concentration of plasma short-chain fatty acids
Time frame: Change from the baseline at 6 weeks
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 22 Apr 2020.
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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 arabinogalactan and maltodextrin in people with Gut Microbiota, run by Biofortis, Merieux NutriSciences at 1 site in United States.
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 10 inclusion and 24 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 22 Apr 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
composition of fecal microbiome (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. 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 22 Apr 2020.