IBS - Irritable Bowel SyndromeNCT05900752

A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients

A study testing QiMeiYan Probiotics in people with IBS - Irritable Bowel Syndrome and Diarrhea, run by Shenzhen Precision Health Food Technology Co. Ltd., at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this interventional clinical study is to study whether the consumption of QiMeiYan Probiotics in 25-35 young people with Mild irritable bowel syndrome (IBS Score 75 - 175) will reduce the frequency of Diarrhea. Read more about this study

Who is it for?: Ages 25 to 35 yearsHealthy volunteers can take part
Conditions the study is for: IBS - Irritable Bowel Syndrome, Diarrhea
What is being tested?: QiMeiYan Probiotics
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 2 sitesChina
Study dates: 19 Jun 2023to 16 Jul 2023
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 25 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Chinese males or females, age between 25-35, the ratio is 1:1;
Mild irritable bowel syndrome diagnosed by IBS-SSS, IBS Score 75 - 175;
Subjects agree not to take any other probiotics during the trial;
Willing not to participate in other interventional clinical studies during the period of this trial;
Fully understand the purpose, benefits obtained, possible risks and side effects of the study;
Willing to comply with all research requirements and procedures;
Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.

Who cannot join

In the treatment of gastrointestinal symptoms;
Lactose intolerance;
Suffering from other organic diseases currently that affect the intestinal function, such as history, colon or rectal cancer resection of gastrointestinal tract, inflammatory bowel disease, diabetes, thyroid function hyperfunction or decline, congenital megacolon, scleroderma, anorexia, etc.;
Controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months;
Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
Abuse alcohol or other drugs, supplement or OTC drugs currently or in the past may cause bowel dysfunction or can affect test result evaluation;

Show all 9Show fewer

Take drugs frequently that may affect gastrointestinal function or the immune system according to PI's judgment;
Use laxatives or other substances that promote digestion 2 weeks before the trial;
Take dairy products or other foods containing prebiotics/bacteria 10 days before the trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Meinian Clinical, Chengdu branch
Chengdu, Sichuan
Ai'er Hospital
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients: A Two-Center, Randomized, Double-Blind, Placebo-controlled Study

140 eligible participants (70 males and 70 females) will be enrolled in two study sites and randomly assigned to two groups of products QiMeiYan Probiotics and placebo. All participants will consume assigned products once a day after meals and record the critical data such as photo of feces. Three site visits will be arranged and all clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis.

Researchers will compare the two groups to validate if the daily consumption of QiMeiYan Probiotics will reduce the frequency of Diarrhea in the study population.

Conditions: IBS - Irritable Bowel Syndrome, Diarrhea
Being tested: QiMeiYan Probiotics, Placebo product
Keywords: Probiotics, QiMeiYan
Medical subject headings: Irritable Bowel Syndrome, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QiMeiYan ProbioticsDietary supplement
consume one sachet of the assigned product, once a day after meals.
Placebo productDietary supplement
consume one sachet of the assigned product, once a day after meals.

Study groups in NCT05900752
Study group	Role	What they receive
QiMeiYan Probiotics	Active comparator	1.5g/ sachet, containing the following ingredients: * Bifidobacterium animalis subsp. lactis V9 * Lactobacillus casei Zhang * Lactobacillus plantarum P-9 * Lactobacillus plantarum CCFM1143 * Xylo-oligosaccharide * Maltodextrin * Resistant Dextrin * Blueberry powder Receives: Dietary Supplement: QiMeiYan Probiotics
Placebo product	Placebo comparator	1.5g/sachet, containing the following ingredients: * Maltodextrin * Blueberry powder Receives: Dietary Supplement: Placebo product

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Diarrhea in IBS-D Patients
Frequency of Diarrhea in IBS-D Patients for the two groups of participants during the study period
Measured: baseline day 0, day 28

Secondary outcomes (2)

Change of Score of IBS-SSS
Change of Score of IBS-SSS for the two groups of participants during the study period. The score of 75-175 is defined as mild severity, 175-300 as middle level severity and >300 as serious level.
Measured: baseline day 0, day14, day 28
Change of Bristol Stool Scale of the feces
Change of Bristol Stool Scale (1-7) of the feces for the two groups of participants during the study period. There are 7 types of feces that matches the look and form of bowel movements indicating potential diarrhea or constipation.
Measured: baseline day 0, day 7, day 14, day 21, day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 202316 Jul 2023

First posted13 Jun 2023
Study start19 Jun 2023
Primary completion16 Jul 2023
Study completion16 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for IBS - Irritable Bowel SyndromeStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05900752
Sponsor's protocol ID: 23-SM-05-WL-001
Status last verified: Nov 2023
First submitted: 2 Jun 2023
Last updated: 24 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Merecz K, Hirsa M, Biniszewska O, Fichna J, Tarasiuk A. An overview of 5-HT3 receptor antagonists as a treatment option for irritable bowel syndrome with diarrhea. Expert Opin Pharmacother. 2023 May-Aug;24(10):1189-1198. doi: 10.1080/14656566.2023.2214314. Epub 2023 May 25.
PubMed 37173833
Shaikh OA, Shaikh G, Aftab RM, Baktashi H, Ullah I, Asghar MS. Unconventional but effective: breaking through IBS-D clinical practice guidelines - correspondence. Ann Med Surg (Lond). 2023 Mar 27;85(4):1312-1313. doi: 10.1097/MS9.0000000000000338. eCollection 2023 Apr.
PubMed 37113818
Kim J, Cho K, Kim JS, Jung HC, Kim B, Park MS, Ji GE, Cho JY, Hong KS. Probiotic treatment induced change of inflammation related metabolites in IBS-D patients/double-blind, randomized, placebo-controlled trial. Food Sci Biotechnol. 2019 Dec 23;29(6):837-844. doi: 10.1007/s10068-019-00717-2. eCollection 2020 Jun.
PubMed 32523793
Li Y, Hong G, Yang M, Li G, Jin Y, Xiong H, Qian W, Hou X. Fecal bacteria can predict the efficacy of rifaximin in patients with diarrhea-predominant irritable bowel syndrome. Pharmacol Res. 2020 Sep;159:104936. doi: 10.1016/j.phrs.2020.104936. Epub 2020 May 26.
PubMed 32470562
Ao W, Cheng Y, Chen M, Wei F, Yang G, An Y, Mao F, Zhu X, Mao G. Intrinsic brain abnormalities of irritable bowel syndrome with diarrhea: a preliminary resting-state functional magnetic resonance imaging study. BMC Med Imaging. 2021 Jan 6;21(1):4. doi: 10.1186/s12880-020-00541-9.
PubMed 33407222
Zhang L, Gong M, Tang Y. A commentary on "The efficacy and safety of probiotics in patients with irritable bowel syndrome: Evidence based on 35 randomized controlled trials" (Int J Surg 2020; 75:116-127). Int J Surg. 2020 Apr;76:70. doi: 10.1016/j.ijsu.2020.02.019. Epub 2020 Feb 24. No abstract available.
PubMed 32105897
Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
PubMed 24076059
Hellstrom PM. Pathophysiology of the irritable bowel syndrome - Reflections of today. Best Pract Res Clin Gastroenterol. 2019 Jun-Aug;40-41:101620. doi: 10.1016/j.bpg.2019.05.007. Epub 2019 May 24.
PubMed 31594651
Delgado-Herrera L, Lasch K, Zeiher B, Lembo AJ, Drossman DA, Banderas B, Rosa K, Lademacher C, Arbuckle R. Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Ther Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.
PubMed 28932269
Szarka LA, Camilleri M, Burton D, Fox JC, McKinzie S, Stanislav T, Simonson J, Sullivan N, Zinsmeister AR. Efficacy of on-demand asimadoline, a peripheral kappa-opioid agonist, in females with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1268-75. doi: 10.1016/j.cgh.2007.07.011. Epub 2007 Sep 27.
PubMed 17900994
Wu H, Zhan K, Rao K, Zheng H, Qin S, Tang X, Huang S. Comparison of five diarrhea-predominant irritable bowel syndrome (IBS-D) rat models in the brain-gut-microbiota axis. Biomed Pharmacother. 2022 May;149:112811. doi: 10.1016/j.biopha.2022.112811. Epub 2022 Mar 15.
PubMed 35303570
Levio S, Cash BD. The place of eluxadoline in the management of irritable bowel syndrome with diarrhea. Ther Adv Gastroenterol. 2017 Sep;10(9):715-725. doi: 10.1177/1756283X17721152. Epub 2017 Jul 24.
PubMed 28932272
Sadrin S, Sennoune S, Gout B, Marque S, Moreau J, Zinoune K, Grillasca JP, Pons O, Maixent JM. A 2-strain mixture of Lactobacillus acidophilus in the treatment of irritable bowel syndrome: A placebo-controlled randomized clinical trial. Dig Liver Dis. 2020 May;52(5):534-540. doi: 10.1016/j.dld.2019.12.009. Epub 2020 Jan 15.
PubMed 31952938
Waller PA, Gopal PK, Leyer GJ, Ouwehand AC, Reifer C, Stewart ME, Miller LE. Dose-response effect of Bifidobacterium lactis HN019 on whole gut transit time and functional gastrointestinal symptoms in adults. Scand J Gastroenterol. 2011 Sep;46(9):1057-64. doi: 10.3109/00365521.2011.584895. Epub 2011 Jun 13.
PubMed 21663486

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All IBS - Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients: A Two-Center, Randomized, Double-Blind, Placebo-controlled Study
ClinicalTrials.gov ID: NCT05900752
Acronym / sponsor ID: 23-SM-05-WL-001
Conditions: IBS - Irritable Bowel Syndrome, Diarrhea
Keywords: Probiotics, QiMeiYan
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,Other government
Study start: 19 Jun 2023 (actual)
Primary completion: 16 Jul 2023 (actual)
Study completion: 16 Jul 2023 (actual)
First posted: 13 Jun 2023 (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.

Researchers will compare the two groups to validate if the daily consumption of QiMeiYan Probiotics will reduce the frequency of Diarrhea in the study population.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
QiMeiYan Probiotics	Active comparator	Dietary Supplement: QiMeiYan Probiotics1.5g/ sachet, containing the following ingredients: * Bifidobacterium animalis subsp. lactis V9 * Lactobacillus casei Zhang * Lactobacillus plantarum P-9 * Lactobacillus plantarum CCFM1143 * Xylo-oligosaccharide * Maltodextrin * Resistant Dextrin * Blueberry powder
Placebo product	Placebo comparator	Dietary Supplement: Placebo product1.5g/sachet, containing the following ingredients: * Maltodextrin * Blueberry powder

Who may qualify

Ages: 25 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Chinese males or females, age between 25-35, the ratio is 1:1;
Mild irritable bowel syndrome diagnosed by IBS-SSS, IBS Score 75 - 175;
Subjects agree not to take any other probiotics during the trial;
Willing not to participate in other interventional clinical studies during the period of this trial;
Fully understand the purpose, benefits obtained, possible risks and side effects of the study;

Key exclusion criteria (9 listed)

In the treatment of gastrointestinal symptoms;
Lactose intolerance;
Suffering from other organic diseases currently that affect the intestinal function, such as history, colon or rectal cancer resection of gastrointestinal tract, inflammatory bowel disease, diabetes, thyroid function hyperfunction or decline, congenital megacolon, scleroderma, anorexia, etc.;
Controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months;
Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;

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
QiMeiYan Probioticsconsume one sachet of the assigned product, once a day after meals.	Dietary supplement	QiMeiYan Probiotics
Placebo productconsume one sachet of the assigned product, once a day after meals.	Dietary supplement	Placebo product

Primary outcome

Frequency of Diarrhea in IBS-D Patients
Time frame: baseline day 0, day 28
Frequency of Diarrhea in IBS-D Patients for the two groups of participants during the study period

2 secondary outcomes

Change of Score of IBS-SSS
Time frame: baseline day 0, day14, day 28
Change of Bristol Stool Scale of the feces
Time frame: baseline day 0, day 7, day 14, day 21, day 28

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 24 Nov 2023.
Background: PubMed 37173833Merecz K, Hirsa M, Biniszewska O, Fichna J, Tarasiuk A. An overview of 5-HT3 receptor antagonists as a treatment option for irritable bowel syndrome with diarrhea. Expert Opin Pharmacother. 2023 May-Aug;24(10):1189-1198. doi: 10.1080/14656566.2023.2214314. Epub 2023 May 25.
Background: PubMed 37113818Shaikh OA, Shaikh G, Aftab RM, Baktashi H, Ullah I, Asghar MS. Unconventional but effective: breaking through IBS-D clinical practice guidelines - correspondence. Ann Med Surg (Lond). 2023 Mar 27;85(4):1312-1313. doi: 10.1097/MS9.0000000000000338. eCollection 2023 Apr.
Background: PubMed 32523793Kim J, Cho K, Kim JS, Jung HC, Kim B, Park MS, Ji GE, Cho JY, Hong KS. Probiotic treatment induced change of inflammation related metabolites in IBS-D patients/double-blind, randomized, placebo-controlled trial. Food Sci Biotechnol. 2019 Dec 23;29(6):837-844. doi: 10.1007/s10068-019-00717-2. eCollection 2020 Jun.
Background: PubMed 32470562Li Y, Hong G, Yang M, Li G, Jin Y, Xiong H, Qian W, Hou X. Fecal bacteria can predict the efficacy of rifaximin in patients with diarrhea-predominant irritable bowel syndrome. Pharmacol Res. 2020 Sep;159:104936. doi: 10.1016/j.phrs.2020.104936. Epub 2020 May 26.
Background: PubMed 33407222Ao W, Cheng Y, Chen M, Wei F, Yang G, An Y, Mao F, Zhu X, Mao G. Intrinsic brain abnormalities of irritable bowel syndrome with diarrhea: a preliminary resting-state functional magnetic resonance imaging study. BMC Med Imaging. 2021 Jan 6;21(1):4. doi: 10.1186/s12880-020-00541-9.
Background: PubMed 32105897Zhang L, Gong M, Tang Y. A commentary on "The efficacy and safety of probiotics in patients with irritable bowel syndrome: Evidence based on 35 randomized controlled trials" (Int J Surg 2020; 75:116-127). Int J Surg. 2020 Apr;76:70. doi: 10.1016/j.ijsu.2020.02.019. Epub 2020 Feb 24. No abstract available.
Background: PubMed 24076059Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
Background: PubMed 31594651Hellstrom PM. Pathophysiology of the irritable bowel syndrome - Reflections of today. Best Pract Res Clin Gastroenterol. 2019 Jun-Aug;40-41:101620. doi: 10.1016/j.bpg.2019.05.007. Epub 2019 May 24.
Background: PubMed 28932269Delgado-Herrera L, Lasch K, Zeiher B, Lembo AJ, Drossman DA, Banderas B, Rosa K, Lademacher C, Arbuckle R. Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Ther Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.
Background: PubMed 17900994Szarka LA, Camilleri M, Burton D, Fox JC, McKinzie S, Stanislav T, Simonson J, Sullivan N, Zinsmeister AR. Efficacy of on-demand asimadoline, a peripheral kappa-opioid agonist, in females with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1268-75. doi: 10.1016/j.cgh.2007.07.011. Epub 2007 Sep 27.
Background: PubMed 35303570Wu H, Zhan K, Rao K, Zheng H, Qin S, Tang X, Huang S. Comparison of five diarrhea-predominant irritable bowel syndrome (IBS-D) rat models in the brain-gut-microbiota axis. Biomed Pharmacother. 2022 May;149:112811. doi: 10.1016/j.biopha.2022.112811. Epub 2022 Mar 15.
Background: PubMed 28932272Levio S, Cash BD. The place of eluxadoline in the management of irritable bowel syndrome with diarrhea. Ther Adv Gastroenterol. 2017 Sep;10(9):715-725. doi: 10.1177/1756283X17721152. Epub 2017 Jul 24.

Related trials for IBS - Irritable Bowel Syndrome

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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.

Ruiming Xu, MD principal investigator

Shanghai Jiao Tong University School of Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing QiMeiYan Probiotics in people with IBS - Irritable Bowel Syndrome and Diarrhea, run by Shenzhen Precision Health Food Technology Co. Ltd., at 2 sites 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 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Frequency of Diarrhea in IBS-D Patients (time frame: baseline day 0, day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900752, which also lists 14 linked publications.

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 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.