search
Back to results

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

Primary Purpose

IBS - Irritable Bowel Syndrome, Diarrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
QiMeiYan Probiotics
Placebo product
Sponsored by
Shenzhen Precision Health Food Technology Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for IBS - Irritable Bowel Syndrome focused on measuring Probiotics, QiMeiYan

Eligibility Criteria

25 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • Ai'er Hospital
  • Meinian Clinical, Chengdu branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

QiMeiYan Probiotics

Placebo product

Arm Description

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

1.5g/sachet, containing the following ingredients: Maltodextrin Blueberry powder

Outcomes

Primary Outcome Measures

Frequency of Diarrhea in IBS-D Patients
Frequency of Diarrhea in IBS-D Patients for the two groups of participants during the study period

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 2, 2023
Last Updated
June 2, 2023
Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,
search

1. Study Identification

Unique Protocol Identification Number
NCT05900752
Brief Title
A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients
Official Title
A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients: A Two-Center, Randomized, Double-Blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 26, 2023 (Anticipated)
Primary Completion Date
July 23, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome, Diarrhea
Keywords
Probiotics, QiMeiYan

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QiMeiYan Probiotics
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo product
Arm Type
Placebo Comparator
Arm Description
1.5g/sachet, containing the following ingredients: Maltodextrin Blueberry powder
Intervention Type
Dietary Supplement
Intervention Name(s)
QiMeiYan Probiotics
Intervention Description
consume one sachet of the assigned product, once a day after meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo product
Intervention Description
consume one sachet of the assigned product, once a day after meals.
Primary Outcome Measure Information:
Title
Frequency of Diarrhea in IBS-D Patients
Description
Frequency of Diarrhea in IBS-D Patients for the two groups of participants during the study period
Time Frame
baseline day 0, day 28
Secondary Outcome Measure Information:
Title
Change of Score of IBS-SSS
Description
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.
Time Frame
baseline day 0, day14, day 28
Title
Change of Bristol Stool Scale of the feces
Description
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.
Time Frame
baseline day 0, day 7, day 14, day 21, day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruiming Xu, MD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ai'er Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Meinian Clinical, Chengdu branch
City
Chengdu
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie Zhang
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
37173833
Citation
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.
Results Reference
background
PubMed Identifier
37113818
Citation
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.
Results Reference
background
PubMed Identifier
32523793
Citation
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.
Results Reference
background
PubMed Identifier
32470562
Citation
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.
Results Reference
background
PubMed Identifier
33407222
Citation
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.
Results Reference
background
PubMed Identifier
32105897
Citation
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.
Results Reference
background
PubMed Identifier
24076059
Citation
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.
Results Reference
background
PubMed Identifier
31594651
Citation
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.
Results Reference
background
PubMed Identifier
28932269
Citation
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. Therap Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.
Results Reference
background
PubMed Identifier
17900994
Citation
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.
Results Reference
background
PubMed Identifier
35303570
Citation
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.
Results Reference
background
PubMed Identifier
28932272
Citation
Levio S, Cash BD. The place of eluxadoline in the management of irritable bowel syndrome with diarrhea. Therap Adv Gastroenterol. 2017 Sep;10(9):715-725. doi: 10.1177/1756283X17721152. Epub 2017 Jul 24.
Results Reference
background
PubMed Identifier
31952938
Citation
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.
Results Reference
background
PubMed Identifier
21663486
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs