Occasional ConstipationNCT07703254
A Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation
A study testing Low-dose Acacia fiber and High-dose Acacia fiber in people with Occasional Constipation and Gastrointestinal Health, run by Nexira at 1 site in Canada.
Trial summary
The goal of this randomized blinded placebo-controlled clinical trial is to investigate the effect of low- and high-dose supplementation of Acacia fiber on gut health and microbiota composition in adults with occasional constipation in a controlled diet context. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Occasional Constipation, Gastrointestinal Health, Gut Microbiota Composition
- What is being tested?
- Low-dose Acacia fiber and High-dose Acacia fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged between 30 and 60 years old, inclusive
- Body Mass Index (BMI) between 18.5 to 29.9 kg/m², inclusive
- Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)
- Participants must meet the following criteria of occasional constipation for the past 3 months. This will be assessed at screening and confirmed over a 2-week period prior to baseline:
- 5 CSBMs per week AND either one of the following: at least 25% of Bowel Movements (BMs) are BSS type 1 or 2 OR straining for most of the BMs (≥50%), defined as 3 minutes or more during BM, as assessed by the QI
- OR,
Show all 23Show fewer
- At least 50% of BMs are BSS type 1 and 2, as assessed by the QI
- OR,
- ≤ 3 CSBMs per week as assessed by the QI
- Low to moderate fiber intake, defined as < 18 g per day for women and < 22 g per day for men, as assessed by the Food Frequency Questionnaire (FFQ)
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- OR,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- Agrees to maintain current lifestyle habits (diet, sleep, physical activity, medications, supplements, and without any new addition) as much as possible throughout the study
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI)
- Willing and able to comply with the study protocol (e.g., concomitant treatment) and complete questionnaires, records and diaries associated with the study, as well as complete all clinic visits
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity or intolerance, to study products
- Chronic constipation, as assessed by the QI
- Following a specific diet (e.g., vegetarian, paleo, ketogenic, carnivore)
- Colonoscopy within four weeks prior to baseline or during the study
- Gastrointestinal related sensitivities including gluten and lactose intolerance
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- Current or history of any significant diseases of the gastrointestinal tract (e.g., irritable bowel syndrome, irritable bowel disease, gastrointestinal surgery) as assessed by the QI
- Unstable metabolic disease, autoimmune disease or chronic diseases as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 8.3.1)
- Type I diabetes
- Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an Hemoglobin A1c (HbA1c) of <8.0% may be included after assessment by the QI on a case-by-case basis
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of prescribed cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout for at least 60 days and abstain for the duration of the study period
- Regular use of tobacco or nicotine products within the past three years, as assessed by the QI.
- Alcohol intake average of >2 per day or >10 per week of standard drinks as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product, gut transit and/or constipation, or gut microbiota characteristics (e.g., fibre, pre- pro- postbiotic, polyphenols extract, etc.) (Section 8.3)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 60 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Triple-Blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation
The goal of this randomized blinded placebo-controlled clinical trial is to investigate the effect of low- and high-dose supplementation of Acacia fiber on gut health and microbiota composition in adults with occasional constipation in a controlled diet context. Acacia fiber is a soluble dietary fiber with prebiotic properties, and this study evaluates its role in modulating gut microbiota and associated gastrointestinal outcomes. Acacia fiber has previously demonstrated improvements in stool frequency in the context of an irritable bowel syndrome with constipation (IBS-C)-characterized population. The main questions this study aims to answer are: Does Acacia fiber supplementation (5 g or 10 g) improve the frequency of bowel movements or stool consistency (assessed by Bristol Stool Scale) in the context of healthy population with occasional constipation? Does Acacia fiber benefit on gut health correlates with specific gut microbiota modulation characterised by shotgun sequencing? What are mechanistical faecal \& blood markers that may support this correlation? Researchers will compare low-dose Acacia fiber (5 g), high-dose Acacia fiber (10 g), and placebo to see if Acacia fiber modulates gut microbiota composition in a manner consistent with prebiotic activity and whether these changes are associated with improvements in bowel movement frequency and stool consistency. Participants will:
- Take a daily supplement of either 5 g Acacia fiber, 10 g Acacia fiber, or placebo
- Complete study diaries, including the Bowel Habits Diary and Bristol Stool Scale
- Complete the Patient Assessment of Constipation Quality of Life, modified Gastrointestinal Symptoms Rating Scale, and sleep and stress Likert scales
- Complete 3-day food records
- Being tested
- Placebo powder, Low-dose Acacia fiber, High-dose Acacia fiber
- Keywords
- gum acacia, acacia fiber, prebiotic, gut health, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo powderDietary supplement
Starting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption.
Low-dose Acacia fiberDietary supplement
Starting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption.
High-dose Acacia fiberDietary supplement
Starting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Acacia fiber | Experimental | Not described Receives: Dietary Supplement: Low-dose Acacia fiber |
| High-dose Acacia fiber | Experimental | Not described Receives: Dietary Supplement: High-dose Acacia fiber |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of complete and spontaneous bowel movements
Frequency of complete and spontaneous bowel movements (CSBMs), as assessed by the Bowel Habits Diary (BHD)
Measured: Baseline to Day 56
Stool consistency
Stool consistency, as assessed by the Bristol Stool Scale (BSS). The BSS is a 7-item stool description and image scale that assesses the shape and consistency of stool. Scores range from 1 to 7, with higher scores indicating looser stool consistency and lower scores indicating harder stool consistency.
Measured: Baseline to Day 56
Secondary outcomes (8)
Gut Microbiota Composition
Change from baseline to Day 56 between Acacia fiber (5g or 10g) and placebo in gut microbiota composition, as assessed by fecal microbiome shotgun sequencing
Measured: Baseline to Day 56
Frequency of CSBMs
Change from baseline to Day 28 between Acacia fiber (5g or 10g) and placebo in frequency of CSBMs, as assessed by the BHD
Measured: Baseline to Day 28
Stool Consistency
Change from baseline to Day 28 between Acacia fiber (5g or 10g) and placebo in stool consistency, as assessed by the Bristol Stool Scale (BSS). The BSS is a 7-item stool description and image scale that assesses the shape and consistency of stool. Scores range from 1 to 7, with higher scores indicating looser stool consistency and lower scores indicating harder stool consistency.
Measured: Baseline to Day 28
Digestive symptoms
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in digestive symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS). The modified GSRS consists of 14 items on a four-point scale (0-3). It assesses abdominal pain, reflux syndrome, diarrhea syndrome, indigestion syndrome, and constipation syndrome. Higher scores indicate more severe gastrointestinal symptoms.
Measured: Baseline to Day 28 and Day 56
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL)
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in Quality of life as assessed by Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL). The PAC-QoL consists of 28-items with four subscales (worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction), and an overall scale. Items are scored on a 5-point Likert scale ranging from 0 to 4, with lower scores indicating better constipation-related quality of life.
Measured: Baseline to Day 28 and Day 56
Proportion of CSBMs with complete defecation
The difference in the proportion of CSBMs with complete defecation at Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo
Measured: Day 28 and Day 56
proportion of participants with occasional constipation
The difference in the proportion of participants with occasional constipation at Day 56 between Acacia fiber (5g or 10g) and placebo
Measured: Day 56
Sleep and Stress
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in sleep and stress, as assessed by the sleep and stress Likert scales. Four-point Likert scales will be used to measure the participant's perceived sleep quality (strongly disagree - 0, disagree - 1, agree - 2, strongly agree - 3) and stress (no stress - 0, minimally stressed - 1, moderately stressed - 2, extremely stressed - 3). Participants will be instructed to indicate their response on the scale for the following statements: "Overall, I am satisfied with my sleep" and " Rate your current stress level". Higher scores indicate greater perceived stress.
Measured: Baseline to Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occasional 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexira
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703254
- Sponsor's protocol ID
- FIB16 / 25NXCRR01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-Blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation
- ClinicalTrials.gov ID
- NCT07703254
- Acronym / sponsor ID
- FIB16 / 25NXCRR01
- Keywords
- gum acacia, acacia fiber, prebiotic, gut health, microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- NexiraIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jul 2026 (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.
The goal of this randomized blinded placebo-controlled clinical trial is to investigate the effect of low- and high-dose supplementation of Acacia fiber on gut health and microbiota composition in adults with occasional constipation in a controlled diet context. Acacia fiber is a soluble dietary fiber with prebiotic properties, and this study evaluates its role in modulating gut microbiota and associated gastrointestinal outcomes. Acacia fiber has previously demonstrated improvements in stool frequency in the context of an irritable bowel syndrome with constipation (IBS-C)-characterized population. The main questions this study aims to answer are: Does Acacia fiber supplementation (5 g or 10 g) improve the frequency of bowel movements or stool consistency (assessed by Bristol Stool Scale) in the context of healthy population with occasional constipation? Does Acacia fiber benefit on gut health correlates with specific gut microbiota modulation characterised by shotgun sequencing? What are mechanistical faecal \& blood markers that may support this correlation? Researchers will compare low-dose Acacia fiber (5 g), high-dose Acacia fiber (10 g), and placebo to see if Acacia fiber modulates gut microbiota composition in a manner consistent with prebiotic activity and whether these changes are associated with improvements in bowel movement frequency and stool consistency. Participants will:
- Take a daily supplement of either 5 g Acacia fiber, 10 g Acacia fiber, or placebo
- Complete study diaries, including the Bowel Habits Diary and Bristol Stool Scale
- Complete the Patient Assessment of Constipation Quality of Life, modified Gastrointestinal Symptoms Rating Scale, and sleep and stress Likert scales
- Complete 3-day food records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose Acacia fiber | Experimental | Dietary Supplement: Low-dose Acacia fiber |
| High-dose Acacia fiber | Experimental | Dietary Supplement: High-dose Acacia fiber |
| Placebo | Placebo comparator | Dietary Supplement: Placebo powder |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Males and females aged between 30 and 60 years old, inclusive
- Body Mass Index (BMI) between 18.5 to 29.9 kg/m², inclusive
- Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)
- Participants must meet the following criteria of occasional constipation for the past 3 months. This will be assessed at screening and confirmed over a 2-week period prior to baseline:
- OR,
Key exclusion criteria (30 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity or intolerance, to study products
- Chronic constipation, as assessed by the QI
- Following a specific diet (e.g., vegetarian, paleo, ketogenic, carnivore)
- Colonoscopy within four weeks prior to baseline or during the study
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 |
|---|---|---|
| Placebo powderStarting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption. | Dietary supplement | Placebo |
| Low-dose Acacia fiberStarting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption. | Dietary supplement | Low-dose Acacia fiber |
| High-dose Acacia fiberStarting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption. | Dietary supplement | High-dose Acacia fiber |
Primary outcome
Frequency of complete and spontaneous bowel movements
Time frame: Baseline to Day 56
Frequency of complete and spontaneous bowel movements (CSBMs), as assessed by the Bowel Habits Diary (BHD)
Stool consistency
Time frame: Baseline to Day 56
Stool consistency, as assessed by the Bristol Stool Scale (BSS). The BSS is a 7-item stool description and image scale that assesses the shape and consistency of stool. Scores range from 1 to 7, with higher scores indicating looser stool consistency and lower scores indicating harder stool consistency.
8 secondary outcomes
Gut Microbiota Composition
Time frame: Baseline to Day 56
Frequency of CSBMs
Time frame: Baseline to Day 28
Stool Consistency
Time frame: Baseline to Day 28
Digestive symptoms
Time frame: Baseline to Day 28 and Day 56
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL)
Time frame: Baseline to Day 28 and Day 56
Proportion of CSBMs with complete defecation
Time frame: Day 28 and Day 56
proportion of participants with occasional constipation
Time frame: Day 56
Sleep and Stress
Time frame: Baseline to Day 28 and Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose Acacia fiber and High-dose Acacia fiber in people with Occasional Constipation and Gastrointestinal Health, run by Nexira at 1 site in Canada.
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 23 inclusion and 30 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: opening soon, as of the sponsor's last update on 14 Jul 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (1-226-242-4551 ext. 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of complete and spontaneous bowel movements (time frame: Baseline to Day 56). 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 14 Jul 2026.