ConstipationNCT06274242
Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults
A study testing Haruna in people with Constipation, run by Mahidol University at 1 site in Thailand.
Trial summary
Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Haruna
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteThailand
- Study dates
- 10 Mar 2023to 8 Jan 2024
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults with a Body mass index (BMI) of 16.00 to 29.99 kg/m2
- Self-reported constipation according to the Rome IV criteria
Who cannot join
- Pregnancy
- Crohn's disease or any other inflammatory bowel disease
- Pelvic floor dyssynergia
- Have congenital diseases such as liver disease, diabetes, and thyroid dysfunction. hypercalcemia neurological disease
- Drink alcohol or smoke regularly.
- During the past 1 month or while in the project, have received antibiotics, steroids, NSAIDs, blood pressure-lowering drugs, antidepressants, anticonvulsants, or Parkinson's disease medications
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- History of food allergy to Haruna's ingredients
- There has been a change in body weight (increase or decrease of 5 kilograms over a period of 6 months).
- During the past 2 weeks or while in the project, have received probiotics or other prebiotics
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Mahidol University
Nakhon Pathom, Changwat Nakhon Pathom, 73170
About this study
Official title: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.
Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.
- Conditions
- Constipation
- Being tested
- Haruna, Placebo Powder
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HarunaDietary supplement
Mixed Natural Prebiotic-Fibers (Ginkgo nut, Spinach, Corn, Brown rice)
Placebo PowderDietary supplement
Isolate Soy Protein and Isomalt
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic arm | Experimental | Not described Receives: Dietary Supplement: Haruna |
| Placebo arm | 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.
Change in Stool Frequency
Stool frequency during the intervention period was determined by modified Constipation scoring system using questionnaire with the following variables: frequency of bowel movements; painful evacuation effort; feeling of incomplete evacuation; abdominal pain; minutes in lavatory per attempt; type of assistance; unsuccessful attempts for evacuation. This consists of six items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 26 (severe constipation).
Measured: 12 weeks
Change in Fecal Microbiota
Change in Bifidobacterium relative abundance with 2log ratio of relative abundance, during the intervention period, compared between prebiotic arm and placebo arm. Subjects with an increase in Bifidobacterium relative abundance were considered to have a good response.
Measured: 12 weeks
Secondary outcomes (1)
Change in Stool consistency
Stool consistency during the intervention period was determined by Bristol stool scale score using questionnaire with the following scale score: 1, separate hard lumps, like nuts; 2, sausage-shaped but lumpy; 3, like a sausage but with cracks on its surface; 4, like a sausage or snake, smooth and soft; 5, soft blobs with clear-cut edges; 6, fluffy pieces with ragged edges, a mushy stool; 7, watery, no solid pieces. 1-2 scale indicate constipation. 3-4 scale are ideal stools as they are easier to pass. 5-7 scale may indicate diarrhea and urgency.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Mar 2023
- Primary completion22 Jul 2023
- Study completion8 Jan 2024
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirirat Luk-In, Mahidol University
- Investigators
- Sirirat Luk-in, phD, Principal investigator, Department of Clinical Microbiology and Applied Technology, Faculty of Medical Technology, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274242
- Sponsor's protocol ID
- MU-CIRB 2022/300.0711
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of this research project.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06274242
- Acronym / sponsor ID
- MU-CIRB 2022/300.0711
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 23 Feb 2024 (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.
Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic arm | Experimental | Dietary Supplement: Haruna |
| Placebo arm | Placebo comparator | Dietary Supplement: Placebo Powder |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults with a Body mass index (BMI) of 16.00 to 29.99 kg/m2
- Self-reported constipation according to the Rome IV criteria
Key exclusion criteria (9 listed)
- Pregnancy
- Crohn's disease or any other inflammatory bowel disease
- Pelvic floor dyssynergia
- Have congenital diseases such as liver disease, diabetes, and thyroid dysfunction. hypercalcemia neurological disease
- Drink alcohol or smoke regularly.
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 |
|---|---|---|
| HarunaMixed Natural Prebiotic-Fibers (Ginkgo nut, Spinach, Corn, Brown rice) | Dietary supplement | Prebiotic arm |
| Placebo PowderIsolate Soy Protein and Isomalt | Dietary supplement | Placebo arm |
Primary outcome
Change in Stool Frequency
Time frame: 12 weeks
Stool frequency during the intervention period was determined by modified Constipation scoring system using questionnaire with the following variables: frequency of bowel movements; painful evacuation effort; feeling of incomplete evacuation; abdominal pain; minutes in lavatory per attempt; type of assistance; unsuccessful attempts for evacuation. This consists of six items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 26 (severe constipation).
Change in Fecal Microbiota
Time frame: 12 weeks
Change in Bifidobacterium relative abundance with 2log ratio of relative abundance, during the intervention period, compared between prebiotic arm and placebo arm. Subjects with an increase in Bifidobacterium relative abundance were considered to have a good response.
1 secondary outcome
Change in Stool consistency
Time frame: 12 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 7 Oct 2026.
- Individual participant dataSharing planned: Yes. After the publication of this research project.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
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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.
Sirirat Luk-in, phD principal investigator
Department of Clinical Microbiology and Applied Technology, Faculty of Medical Technology, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haruna in people with Constipation, run by Mahidol University at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 7 Oct 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 Thailand. 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?
Change in Stool Frequency (time frame: 12 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 7 Oct 2026.