Efficacy of Lacticaseibacillus Paracasei Strain Shirota on Clinical Manifestation of Functional Constipation in Mexican Adults

NCT06432608 | Not Yet Recruiting DMC

• 1 other identifier: UDG-FC-2024
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic functional constipation is a gastrointestinal disorder with an approximate prevalence of 14% of the Mexican population, which is characterized by difficult or incomplete defecation and/or infrequent bowel movements, with the absence of symptoms such as abdominal pain or inflammation, and in If they occur, they should not be the predominant symptoms. Its origin is multifactorial and includes variables such as diet, water consumption, alteration in motility, and intestinal microbiota, the latter as a source of different secondary metabolites such as short-chain fatty acids (SCFAs). Lower SCFA values in constipation would alter the relationship between them, increasing the risk of clinical manifestations of functional chronic constipation. In addition to physical discomfort, subjects with this disease manifest alterations in their quality of life. Recent studies have suggested using probiotic microorganisms to treat this functional disorder due to their beneficial effects on evacuation frequency, SCFAs, and quality of life. However, in Mexico, knowledge of the above is limited. Therefore, this research aims to determine the effect of consuming a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota on the clinical manifestations of functional constipation in Mexican adults and its relationship with SCFAs.

Conditions

Constipation

Keywords

functional constipation; clinical manifestation; mexican; short fatty acids; Lacticaseibacillus paracasei strain Shirota

Outcome Measures

Primary Outcomes (1)

• Clinical manifestation of functional constipation

  Clinical manifestation will be measure by Bristol scale (1-2 hard stools; 3-4 normal; 4-5 soft stools), Frequency of bowel movements will be obtained by the question of how many times per week have defecated, meanwhile severity of symptoms related to constipation will include indicators of difficulty passing stool, pain, and feeling of incomplete evacuation on a 4-point scale (1, none; 2, a little; 3, some; and 4, a lot)

  2 months

Secondary Outcomes (4)

• Analysis of short-chain fatty acids

  2 months

• Height

  2 months

• Body weight

  2 months

• Body Mass Index (BMI)

  2 months

Study Arms (1)

Experimental group

EXPERIMENTAL

The single arm contemplates providing the study subjects diagnosed with functional constipation with a product based on fermented milk (80mL) daily for 4 weeks.

Dietary Supplement: fermented milk, Yakult

Interventions

fermented milk, Yakult DIETARY_SUPPLEMENT

Study subjects will be provided with a product based on fermented milk, Yakult (80mL) daily for four weeks in order to know the effects of clinical manifestation of functional constipation and short-fatty acids in the Mexican population

Experimental group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between 20 and 60 years old, diagnosed with functional chronic constipation (according to the Rome IV criteria).
• Men and women who have given informed consent.

You may not qualify if:

• Constipation due to neurological, pharmacological or organic causes.
• Pregnancy or pregnancy expected within the next month.
• Breastfeeding women.
• Diagnosed pathologies such as: diabetes mellitus, kidney or liver failure, infectious disease, inflammatory disease or any neoplastic disease.
• Use of laxatives within 14 days prior to the start of the intervention.
• Use of antibiotics within 14 days prior to the start of the intervention.
• Diagnosis of cancer in the last three years.
• History of drug and medication abuse.
• Active alcoholism with a daily intake greater than 50 g/day.
• Lactose intolerance.
• Known allergies to any substance in the study product (e.g., cow's milk proteins).
• Any subject who needs manual maneuvers to evacuate feces.
• Anticipated major changes in diet or exercise during the study period.
• Eating disorders.
• Participation in another study with any investigational product within 3 months prior to enrollment.

Sponsors & Collaborators

• University of Guadalajara: lead
• Yakult Honsha Co., LTD: collaborator

Related Publications (13)

• Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren M. An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation. Expert Rev Gastroenterol Hepatol. 2020 Jan;14(1):39-46. doi: 10.1080/17474124.2020.1708718. Epub 2020 Jan 2.

  PMID: 31893959 BACKGROUND

• Araujo MM, Botelho PB. Probiotics, prebiotics, and synbiotics in chronic constipation: Outstanding aspects to be considered for the current evidence. Front Nutr. 2022 Dec 8;9:935830. doi: 10.3389/fnut.2022.935830. eCollection 2022.

  PMID: 36570175 BACKGROUND

• Chen S, Ou Y, Zhao L, Li Y, Qiao Z, Hao Y, Ren F. Differential Effects of Lactobacillus casei Strain Shirota on Patients With Constipation Regarding Stool Consistency in China. J Neurogastroenterol Motil. 2019 Jan 31;25(1):148-158. doi: 10.5056/jnm17085.

  PMID: 30646486 BACKGROUND

• Cheng Y, Liu J, Ling Z. Short-chain fatty acids-producing probiotics: A novel source of psychobiotics. Crit Rev Food Sci Nutr. 2022;62(28):7929-7959. doi: 10.1080/10408398.2021.1920884. Epub 2021 May 6.

  PMID: 33955288 BACKGROUND

• Dimidi E, Christodoulides S, Fragkos KC, Scott SM, Whelan K. The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2014 Oct;100(4):1075-84. doi: 10.3945/ajcn.114.089151. Epub 2014 Aug 6.

  PMID: 25099542 BACKGROUND

• Forootan M, Bagheri N, Darvishi M. Chronic constipation: A review of literature. Medicine (Baltimore). 2018 May;97(20):e10631. doi: 10.1097/MD.0000000000010631.

  PMID: 29768326 BACKGROUND

• Lange O, Proczko-Stepaniak M, Mika A. Short-Chain Fatty Acids-A Product of the Microbiome and Its Participation in Two-Way Communication on the Microbiome-Host Mammal Line. Curr Obes Rep. 2023 Jun;12(2):108-126. doi: 10.1007/s13679-023-00503-6. Epub 2023 May 19.

  PMID: 37208544 BACKGROUND

• Markowiak-Kopec P, Slizewska K. The Effect of Probiotics on the Production of Short-Chain Fatty Acids by Human Intestinal Microbiome. Nutrients. 2020 Apr 16;12(4):1107. doi: 10.3390/nu12041107.

  PMID: 32316181 BACKGROUND

• Morrison DJ, Preston T. Formation of short chain fatty acids by the gut microbiota and their impact on human metabolism. Gut Microbes. 2016 May 3;7(3):189-200. doi: 10.1080/19490976.2015.1134082. Epub 2016 Mar 10.

  PMID: 26963409 BACKGROUND

• Simren M, Palsson OS, Whitehead WE. Update on Rome IV Criteria for Colorectal Disorders: Implications for Clinical Practice. Curr Gastroenterol Rep. 2017 Apr;19(4):15. doi: 10.1007/s11894-017-0554-0.

  PMID: 28374308 BACKGROUND

• Schmulson Wasserman M, Francisconi C, Olden K, Aguilar Paiz L, Bustos-Fernandez L, Cohen H, Passos MC, Gonzalez-Martinez MA, Iade B, Iantorno G, Ledesma Ginatta C, Lopez-Colombo A, Perez CL, Madrid-Silva AM, Quilici F, Quintero Samudio I, Rodriguez Varon A, Suazo J, Valenzuela J, Zolezzi A. [The Latin-American Consensus on Chronic Constipation]. Gastroenterol Hepatol. 2008 Feb;31(2):59-74. doi: 10.1157/13116072. Spanish.

  PMID: 18279643 BACKGROUND

• Yuan F, Tan W, Ren H, Yan L, Wang Y, Luo H. The Effects of Short-Chain Fatty Acids on Rat Colonic Hypermotility Induced by Water Avoidance Stress. Drug Des Devel Ther. 2020 Nov 2;14:4671-4684. doi: 10.2147/DDDT.S246619. eCollection 2020.

  PMID: 33173277 BACKGROUND

• Zhuang M, Shang W, Ma Q, Strappe P, Zhou Z. Abundance of Probiotics and Butyrate-Production Microbiome Manages Constipation via Short-Chain Fatty Acids Production and Hormones Secretion. Mol Nutr Food Res. 2019 Dec;63(23):e1801187. doi: 10.1002/mnfr.201801187. Epub 2019 Oct 22.

  PMID: 31556210 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ma.Refugio Torres Vitela, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angélica Villarruel, PhD

CONTACT

52 (33) 1378 5900; angelica.vlopez@academicos.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Original longitudinal, analytical, and prospective quasi-experimental study in adults diagnosed with functional chronic constipation under the ROME IV criteria. The study will provide a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota for 4 weeks.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 29, 2024
• Study Start: June 15, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share