Gut HealthNCT07781488
A Clinical Trial to Evaluate the Effects of a Fibre Supplement on Microbiome and Gut Health
A study testing Essential Fibre+ in people with Gut Health and Microbiome, run by Artah Nutrition Limited at 1 site in United States.
Trial summary
This study will evaluate the effects of the Artah Essential Fibre+ supplement on the microbiome and gut health over an 8-week period. The study is a single-arm, unblinded virtual trial enrolling 50 participants who will consume the test product daily and complete questionnaires at Baseline, Week 2, Week 4, Week 6, and… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Gut Health, Microbiome, Bloating
- What is being tested?
- Essential Fibre+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Sep 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Aged 21-65
- Experiencing issues regarding at least two of the following over the past four weeks: stomach discomfort, constipation, bowel movement regularity, indigestion, diarrhea, bloating, gas, abdominal pain, or excessive food cravings
- Generally healthy - does not live with any uncontrolled chronic disease
- If taking any other supplements or herbal remedies that target gut or digestive health, has been doing so for at least three months consistently, and is willing to maintain this for the duration of the study
- Willing to maintain their current diet, sleep pattern, and activity levels for the duration of the study
- Resides in the United States
Who cannot join
- Anyone unwilling to comply with the study protocol for the duration of the study
- Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, ulcerative colitis (UC), celiac disease, or gastrointestinal tract surgeries
- Anyone with known allergies or hypersensitivities to any supplement product ingredients, including sesame and mustard
- Anyone planning to introduce any other new supplements, prescription medications, or herbal remedies at any point for the duration of the study
- Anyone with chronic health conditions that could impact participation in this study, such as cancer, mental health disorders, a history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period
- Anyone who has taken prescription antibiotics, prebiotics, synbiotics, postbiotics, and/or fiber supplements within the past three months
Show all 9Show fewer
- Has taken weight loss medications (like GLP-1 agonists) in the past three months
- Anyone currently pregnant, trying to conceive, or breastfeeding
- Anyone currently testing, or planning to test, a product during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the effects of the Artah Essential Fibre+ supplement on the microbiome and gut health over an 8-week period. The study is a single-arm, unblinded virtual trial enrolling 50 participants who will consume the test product daily and complete questionnaires at Baseline, Week 2, Week 4, Week 6, and Week 8.
A subgroup of 30 participants will provide stool samples for microbiome testing at Baseline and Week 8. All participants will provide body composition measurements using a smart scale at Baseline, Week 4, and Week 8. Secondary outcomes include participants' self-reported perceptions of the product's effects on gut health, metabolism, food cravings, appetite, and general well-being.
- Conditions
- Gut Health, Microbiome, Bloating, Indigestion, Constipation, Diarrhea
- Being tested
- Essential Fibre+
- Medical subject headings
- Dyspepsia, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Fibre+Dietary supplement
All 50 participants receive the Artah Essential Fibre+ supplement once daily in the morning before the first meal of the day, mixed with 500ml of water. Dosing is graduated: one scoop on Days 1-3, two scoops on Days 4-6, and three scoops from Day 7 onwards for the remainder of the 8-week study period.
| Study group | Role | What they receive |
|---|---|---|
| Essential Fibre+ | Experimental | Not described Receives: Dietary Supplement: Essential Fibre+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Resilience Score
Change from Baseline in Gut Resilience Score assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Hydrogen Sulfide Index
Change from Baseline in Hydrogen Sulfide Index assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Firmicutes/Bacteroidota Ratio
Change from Baseline in Firmicutes/Bacteroidota ratio assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Hexa-LPS Index
Change from Baseline in Hexa-LPS Index assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Mucus Degradation Index
Change from Baseline in Mucus Degradation Index assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Prevotella Abundance
Change from Baseline in Prevotella abundance assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Bacteroides Abundance
Change from Baseline in Bacteroides abundance assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Abundance Index
Change from Baseline in Abundance Index assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Richness Index
Change from Baseline in Richness Index assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Proteobacteria/Actinobacteriota Ratio
Change from Baseline in Proteobacteria/Actinobacteriota ratio assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Butyrate Level
Change from Baseline in Butyrate level assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Acetate Level
Change from Baseline in Acetate level assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Change in Propionate Level
Change from Baseline in Propionate level assessed via stool-based microbiome testing (Tiny Health)
Measured: Baseline and Week 8
Secondary outcomes (5)
Change in Self-Reported Indigestion
Change from Baseline in participant-reported indigestion assessed via self-report questionnaire
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Bloating
Change from Baseline in participant-reported bloating assessed via self-report questionnaire
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Bowel Movement Frequency
Change from Baseline in participant-reported bowel movement frequency assessed via self-report questionnaire
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Food Cravings
Change from Baseline in participant-reported food cravings assessed via self-report questionnaire
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Overall Mood
Change from Baseline in participant-reported overall mood assessed via self-report questionnaire
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artah Nutrition Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781488
- Sponsor's protocol ID
- #20825
- Other IDs
- legacy-_20825
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of a Fibre Supplement on Microbiome and Gut Health
- ClinicalTrials.gov ID
- NCT07781488
- Acronym / sponsor ID
- #20825
- Conditions
- Gut Health, Microbiome, Bloating, Indigestion, Constipation, Diarrhea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Artah Nutrition LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Aug 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.
This study will evaluate the effects of the Artah Essential Fibre+ supplement on the microbiome and gut health over an 8-week period. The study is a single-arm, unblinded virtual trial enrolling 50 participants who will consume the test product daily and complete questionnaires at Baseline, Week 2, Week 4, Week 6, and Week 8.
A subgroup of 30 participants will provide stool samples for microbiome testing at Baseline and Week 8. All participants will provide body composition measurements using a smart scale at Baseline, Week 4, and Week 8. Secondary outcomes include participants' self-reported perceptions of the product's effects on gut health, metabolism, food cravings, appetite, and general well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essential Fibre+ | Experimental | Dietary Supplement: Essential Fibre+ |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Aged 21-65
- Experiencing issues regarding at least two of the following over the past four weeks: stomach discomfort, constipation, bowel movement regularity, indigestion, diarrhea, bloating, gas, abdominal pain, or excessive food cravings
- Generally healthy - does not live with any uncontrolled chronic disease
- If taking any other supplements or herbal remedies that target gut or digestive health, has been doing so for at least three months consistently, and is willing to maintain this for the duration of the study
Key exclusion criteria (9 listed)
- Anyone unwilling to comply with the study protocol for the duration of the study
- Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, ulcerative colitis (UC), celiac disease, or gastrointestinal tract surgeries
- Anyone with known allergies or hypersensitivities to any supplement product ingredients, including sesame and mustard
- Anyone planning to introduce any other new supplements, prescription medications, or herbal remedies at any point for the duration of the study
- Anyone with chronic health conditions that could impact participation in this study, such as cancer, mental health disorders, a history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period
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 |
|---|---|---|
| Essential Fibre+All 50 participants receive the Artah Essential Fibre+ supplement once daily in the morning before the first meal of the day, mixed with 500ml of water. Dosing is graduated: one scoop on Days 1-3, two scoops on Days 4-6, and three scoops from Day 7 onwards for the remainder of the 8-week study period. | Dietary supplement | Essential Fibre+ |
Primary outcome
Change in Gut Resilience Score
Time frame: Baseline and Week 8
Change from Baseline in Gut Resilience Score assessed via stool-based microbiome testing (Tiny Health)
Change in Hydrogen Sulfide Index
Time frame: Baseline and Week 8
Change from Baseline in Hydrogen Sulfide Index assessed via stool-based microbiome testing (Tiny Health)
Change in Firmicutes/Bacteroidota Ratio
Time frame: Baseline and Week 8
Change from Baseline in Firmicutes/Bacteroidota ratio assessed via stool-based microbiome testing (Tiny Health)
Change in Hexa-LPS Index
Time frame: Baseline and Week 8
Change from Baseline in Hexa-LPS Index assessed via stool-based microbiome testing (Tiny Health)
Change in Mucus Degradation Index
Time frame: Baseline and Week 8
Change from Baseline in Mucus Degradation Index assessed via stool-based microbiome testing (Tiny Health)
Change in Prevotella Abundance
Time frame: Baseline and Week 8
Change from Baseline in Prevotella abundance assessed via stool-based microbiome testing (Tiny Health)
Change in Bacteroides Abundance
Time frame: Baseline and Week 8
Change from Baseline in Bacteroides abundance assessed via stool-based microbiome testing (Tiny Health)
Change in Abundance Index
Time frame: Baseline and Week 8
Change from Baseline in Abundance Index assessed via stool-based microbiome testing (Tiny Health)
Change in Richness Index
Time frame: Baseline and Week 8
Change from Baseline in Richness Index assessed via stool-based microbiome testing (Tiny Health)
Change in Proteobacteria/Actinobacteriota Ratio
Time frame: Baseline and Week 8
Change from Baseline in Proteobacteria/Actinobacteriota ratio assessed via stool-based microbiome testing (Tiny Health)
Change in Butyrate Level
Time frame: Baseline and Week 8
Change from Baseline in Butyrate level assessed via stool-based microbiome testing (Tiny Health)
Change in Acetate Level
Time frame: Baseline and Week 8
Change from Baseline in Acetate level assessed via stool-based microbiome testing (Tiny Health)
Change in Propionate Level
Time frame: Baseline and Week 8
Change from Baseline in Propionate level assessed via stool-based microbiome testing (Tiny Health)
5 secondary outcomes
Change in Self-Reported Indigestion
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Bloating
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Bowel Movement Frequency
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Food Cravings
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Self-Reported Overall Mood
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
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 24 Aug 2026.
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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 Essential Fibre+ in people with Gut Health and Microbiome, run by Artah Nutrition Limited 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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 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 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. 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?
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?
Change in Gut Resilience Score (time frame: Baseline and Week 8). The study lists 13 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 24 Aug 2026.