Irritable Bowel Syndrome - DiarrhoeaNCT06779214
Effect of Food-derived Active Components on Digestive Tract Health in Adults With Irritable Bowel Syndrome
A study testing Prebiotic_L, resveratrol_L and Prebiotic_M in people with Irritable Bowel Syndrome - Diarrhoea, run by Peking University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Bifidobacterium. animalis subsp. Lactis A6 Strain or resveratrol to improve the symptoms of diarrhea-predominate irritable bowel syndromes (IBS-D). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome - Diarrhoea
- What is being tested?
- Prebiotic_L, resveratrol_L and Prebiotic_M
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 31 Dec 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- met the Western Medicine Rome IV diagnostic criteria for diarrheal IBS
- 18 and 60 years old
- subjects voluntarily sign informed consent forms.
Who cannot join
- Having a disease that may affect the gut microbiome (e.g., inflammatory bowel disease, celiac disease, diabetes)
- Abdominal pain or diarrhea due to organic disease
- Patients with abdominal surgery
- Patients with serious mental illness and complications of heart, brain, liver, kidney and other systems
- Unable to communicate normally or skilled in the use of communication equipment
- Having serious mental problems or taking related drugs
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- Drug or alcohol abusers
- People with special diets (such as vegetarians) or eating disorders or are receiving therapeutic dietary interventions
- Had used antibiotics, probiotics, other drugs that may affect the study
- Participants who are participating in other clinical trials
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if Bifidobacterium. animalis subsp.
Lactis A6 Strain or resveratrol to improve the symptoms of diarrhea-predominate irritable bowel syndromes (IBS-D). The main questions it aims to answer are:
Read more
- Does Bifidobacterium animalis subsp.Lactis A6 Strain or resveratrol improve the symptoms of IBS-D.
- What is the optimal intervention dose of Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol to improve IBS-D
Researchers will compare Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol interventions to placebo (one look-alike sunbstance that contains no interventions substance) to see if Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol relief the symptoms of patients with IBS-D.
Participants will:
- Take Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol every day for 30 days.
- Visit the clinic once every 15 days for checkups and tests.
Read the detailed description
We recruited patients with IBS-D. The subjects who met the inclusion criteria were randomly divided into placebo control group, Bifidobacterium. animalis subsp.Lactis A6 Strain group and resveratrol intervention. The intervention period lasted for 4 weeks, and the follow-up was conducted every 15 days. The main outcomes were: ① IBS Symptom Severity Scale (IBS-SSS), ② gut microbiota and their metabolites. The secondary outcomes were: ① IBS Quality of Life score (IBS-QOL), ② Bristol fecal traits score, ③hydrogen breath test; ④ Inflammatory markers. After the intervention, statistical analysis was performed on the experimental data to analyze and compare the differences in the main and secondary outcome indicators of the experimental groups, so as to clarify the intervention effect and effective intervention dose of probiotics and resveratrol on diarrheal IBS, and provide scientific basis for the formulation of relevant clinical treatment paths.
- Conditions
- Irritable Bowel Syndrome - Diarrhoea
- Being tested
- Prebiotic_L, resveratrol_L, Prebiotic_M, Prebiotic_H, resveratrol_H
- Keywords
- Diarrhea-predominate Irritable bowel syndrome, probiotics, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic_LDietary supplement
subject will receive a low-dosage (1*10^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
resveratrol_LDietary supplement
subject will receive a low-dosage (300mg/d) of resveratrol
Prebiotic_MDietary supplement
subject will receive a medium-dosage (1*10^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
Prebiotic_HDietary supplement
subjects will receive a high-dosage (1*10^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
resveratrol_HDietary supplement
subject will receive a low-dosage (600mg/d) of resveratrol
placebo_BifOther
subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)
placebo_resveratrolOther
subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
| Study group | Role | What they receive |
|---|---|---|
| resveratrol intervention | Experimental | participants receive different levels of resveratrol Receives: Dietary Supplement: resveratrol_L; Dietary Supplement: resveratrol_H; Other: placebo_resveratrol |
| prebiotic intervention | Experimental | subjects receive different levels of prebiotics Receives: Dietary Supplement: Prebiotic_L; Dietary Supplement: Prebiotic_M; Dietary Supplement: Prebiotic_H; Other: placebo_Bif |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Symptom Severity Scale
it is a scale to evaluate the severity of irritable bowel syndrome symptoms, and the scoring range is from 0 to 500 points. The higher the score, the more severe the symptoms.
Measured: 30 days
IBS Quality of Life
A scoring system is designed to mark changes in quality of life of patients, which includes 34 items with the score range of 34 to 170 scores. The higher the score, the poorer the quality of life.
Measured: 30 days
Secondary outcomes (3)
The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β).
Using the ELISA method to detect inflammatory cytokines above mentioned in the serum of patients, higher levels of inflammatory cytokines suggest that the patient is in an inflammatory state.
Measured: 30 days
Concentration of hydrogen in Hydrogen Breath Test
The hydrogen breath test is used to evaluate whether there is excessive overgrowth of small intestinal bacterial in patients. For subjects, the peak value of hydrogen exceeding 20ppm (parts per million) is considered positive, indicating the presence of small intestinal bacterial overgrowth.
Measured: 30 days
the alpha diversity and composition of gut microbiome
16s rDNA is used to test the diversity and composition of gut microbiome of participants. The alpha diversity is adopted to evaluate the number of species within a community (richness) as well as the distribution of each species (evenness). the higher the indicator, the healthier the gut. The composition of gut microbiome is used to describe the abundance of beneficial and harmful bacteria. The higher the abundance of beneficial bacteria and the lower the abundance of harmful bacteria, the healthier the gut is.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start28 Feb 2025
- Primary completion31 Mar 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome - DiarrhoeaStudies of the same condition, open and under way.
- More trials run by Peking 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779214
- Sponsor's protocol ID
- Xuyajun197673-03
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food-derived Active Components on Digestive Tract Health in Adults With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06779214
- Acronym / sponsor ID
- Xuyajun197673-03
- Conditions
- Irritable Bowel Syndrome - Diarrhoea
- Keywords
- Diarrhea-predominate Irritable bowel syndrome, probiotics, polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Jan 2025 (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 clinical trial is to learn if Bifidobacterium. animalis subsp.
Lactis A6 Strain or resveratrol to improve the symptoms of diarrhea-predominate irritable bowel syndromes (IBS-D). The main questions it aims to answer are:
- Does Bifidobacterium animalis subsp.Lactis A6 Strain or resveratrol improve the symptoms of IBS-D.
- What is the optimal intervention dose of Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol to improve IBS-D
Researchers will compare Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol interventions to placebo (one look-alike sunbstance that contains no interventions substance) to see if Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol relief the symptoms of patients with IBS-D.
Participants will:
- Take Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol every day for 30 days.
- Visit the clinic once every 15 days for checkups and tests.
Detailed description
We recruited patients with IBS-D. The subjects who met the inclusion criteria were randomly divided into placebo control group, Bifidobacterium. animalis subsp.Lactis A6 Strain group and resveratrol intervention. The intervention period lasted for 4 weeks, and the follow-up was conducted every 15 days. The main outcomes were: ① IBS Symptom Severity Scale (IBS-SSS), ② gut microbiota and their metabolites. The secondary outcomes were: ① IBS Quality of Life score (IBS-QOL), ② Bristol fecal traits score, ③hydrogen breath test; ④ Inflammatory markers. After the intervention, statistical analysis was performed on the experimental data to analyze and compare the differences in the main and secondary outcome indicators of the experimental groups, so as to clarify the intervention effect and effective intervention dose of probiotics and resveratrol on diarrheal IBS, and provide scientific basis for the formulation of relevant clinical treatment paths.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resveratrol intervention | Experimental | Dietary Supplement: resveratrol_L, Dietary Supplement: resveratrol_H, Other: placebo_resveratrolparticipants receive different levels of resveratrol |
| prebiotic intervention | Experimental | Dietary Supplement: Prebiotic_L, Dietary Supplement: Prebiotic_M, Dietary Supplement: Prebiotic_H, Other: placebo_Bifsubjects receive different levels of prebiotics |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- met the Western Medicine Rome IV diagnostic criteria for diarrheal IBS
- 18 and 60 years old
- subjects voluntarily sign informed consent forms.
Key exclusion criteria (11 listed)
- Having a disease that may affect the gut microbiome (e.g., inflammatory bowel disease, celiac disease, diabetes)
- Abdominal pain or diarrhea due to organic disease
- Patients with abdominal surgery
- Patients with serious mental illness and complications of heart, brain, liver, kidney and other systems
- Unable to communicate normally or skilled in the use of communication equipment
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 |
|---|---|---|
| Prebiotic_Lsubject will receive a low-dosage (1*10^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain | Dietary supplement | prebiotic intervention |
| resveratrol_Lsubject will receive a low-dosage (300mg/d) of resveratrol | Dietary supplement | resveratrol intervention |
| Prebiotic_Msubject will receive a medium-dosage (1*10^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain | Dietary supplement | prebiotic intervention |
| Prebiotic_Hsubjects will receive a high-dosage (1*10^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain | Dietary supplement | prebiotic intervention |
| resveratrol_Hsubject will receive a low-dosage (600mg/d) of resveratrol | Dietary supplement | resveratrol intervention |
| placebo_Bifsubjects will receive placebo (one look-alike sunbstance that contains no prebiotics) | Other | prebiotic intervention |
| placebo_resveratrolsubjects will receive placebo (one look-alike sunbstance that contains no resveratrol) | Other | resveratrol intervention |
Primary outcome
Irritable Bowel Syndrome Symptom Severity Scale
Time frame: 30 days
it is a scale to evaluate the severity of irritable bowel syndrome symptoms, and the scoring range is from 0 to 500 points. The higher the score, the more severe the symptoms.
IBS Quality of Life
Time frame: 30 days
A scoring system is designed to mark changes in quality of life of patients, which includes 34 items with the score range of 34 to 170 scores. The higher the score, the poorer the quality of life.
3 secondary outcomes
The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β).
Time frame: 30 days
Concentration of hydrogen in Hydrogen Breath Test
Time frame: 30 days
the alpha diversity and composition of gut microbiome
Time frame: 30 days
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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 Prebiotic_L, resveratrol_L and Prebiotic_M in people with Irritable Bowel Syndrome - Diarrhoea, run by Peking University at 1 site in China.
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 3 inclusion and 11 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 20 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 China. 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?
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?
Irritable Bowel Syndrome Symptom Severity Scale (time frame: 30 days). 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 20 Oct 2026.