Not Yet RecruitingNot Applicable

A Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation

Canada105 participantsStarted 2026-07

Plain-language 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. 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

Who can participate

Age range

30 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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, 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of complete and spontaneous bowel movements

Timeframe: Baseline to Day 56

Stool consistency

Timeframe: Baseline to Day 56

Trial details

NCT IDNCT07703254

SponsorNexira

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Erin Lewis, PhD

1-226-242-4551 elewis@kgkscience.com

View on ClinicalTrials.gov More Occasional Constipation trials