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

NCT05900752 | Completed

• 1 other identifier: 23-SM-05-WL-001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

IBS - Irritable Bowel Syndrome; Diarrhea

Keywords

Probiotics; QiMeiYan

Outcome Measures

Primary Outcomes (1)

• Frequency of Diarrhea in IBS-D Patients

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

  baseline day 0, day 28

Secondary Outcomes (2)

• Change of Score of IBS-SSS

  baseline day 0, day14, day 28

• Change of Bristol Stool Scale of the feces

  baseline day 0, day 7, day 14, day 21, day 28

Study Arms (2)

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

Dietary Supplement: QiMeiYan Probiotics

Placebo product

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo product

Interventions

QiMeiYan Probiotics DIETARY_SUPPLEMENT

consume one sachet of the assigned product, once a day after meals.

QiMeiYan Probiotics

Placebo product DIETARY_SUPPLEMENT

consume one sachet of the assigned product, once a day after meals.

Placebo product

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Precision Health Food Technology Co. Ltd.,: lead

Study Sites (2)

Ai'er Hospital

Shanghai, Shanghai Municipality, China

Location

Meinian Clinical, Chengdu branch

Chengdu, Sichuan, China

Location

Related Publications (14)

• 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.

  PMID: 37173833 BACKGROUND

• 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.

  PMID: 37113818 BACKGROUND

• 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.

  PMID: 32523793 BACKGROUND

• 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.

  PMID: 32470562 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 31952938 BACKGROUND

• 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.

  PMID: 21663486 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruiming Xu, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 13, 2023
• Study Start: June 19, 2023
• Primary Completion: July 16, 2023
• Study Completion: July 16, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

CN (2)